9th June 2010 - 23rd March 2011 in Tokyo, Japan [2875]
3rd DIA Regulatory Affairs Training Course
This is a training course for the development and fostering of people from pharmaceutical companies and regulatory authorities engaged in drug development. The course is aimed at providing basic knowledge necessary for a regulatory scientist. The course consists
of ten separate sessions and each session consists of a lecture, small group discussion, and mock exercise. So it is also expected that skills for negotiation and debate will be improved.
Contact: DIA Japan
Telephone: 81-(0)3-5833-8444
Email: diajapan@diajapan.org
Website: http://www.diahome.org/DIAHOME/Education/FindEducationalOffering.aspx?productID=23643&eventType=Meeting
12th 2010 - 12th July 2020 at the Outline in NA, NA [3061]
Validation and Part 11 Compliance
Kaplan eLearning Program
Contact: Katie Hill
Telephone: 215.442.6100
Email: katie.hill@diahome.org
Website: http://www.diahome.org/DIAHome/Education/eLearning.aspx
12th 2010 - 12th July 2020 at the On Line in NA [3059]
Clinical Medical Device Core Program
Kaplan eLearning Program
Contact: Katie Hill
Telephone: 215.442.6100
Email: karie.hill@diahome.org
Website: http://www.diahome.org/DIAHome/Education/eLearning.aspx
12th 2010 - 12th July 2020 at the OnLine in NA [3060]
GMP Pharmaceutical Core Program
Kaplan eLearning Program
Contact: Katie Hill
Telephone: 215.442.6100
Email: katie.hill@diahome.org
Website: http://www.diahome.org/DIAHome/Education/eLearning.aspx
18th - 20th August 2010 in Costa Mesa, CA, USA [2913]
The Drug Development Process - From Discovery to Commercialization
Contact: Michael Roberts
Telephone: 610-688-1708
Email: info@cfpie.com
Website: http://www.cfpie.com/showitem.aspx?productid=025&source=pharmacy
19th - 20th August 2010 in King of Prussia, PA, USA [2914]
Writing in the Regulated Environment When English Is Your Second Language
Contact: Michael Roberts
Telephone: 610-688-1708
Email: info@cfpie.com
Website: http://www.cfpie.com/showitem.aspx?productid=084&source=pharmacy
19th - 20th August 2010 at the Taj Residency (M.G. Road), Bangalore, India in Bangalore, India [3075]
Conference on Clinical Trials Asia Summit 2010
Clinical trials in India are finally becoming transparent. There has been a dramatic increase in the number of trials that have got officially registered in Clinical Trials Registry-India (CTRI). According to records collected by the Indian Council of Medical Research and the Drug Controller General\\\'s office, between July-December 2007, only 11 trials were registered.
Contact: S. Raju
Telephone: + 91 22 27578668; Fax: +91 22 27579131
Email: sandhya@bharatbook.com
Website: http://www.bharatbook.com/detail.asp?id=144475&rt=Conference-on-Clinical-Trials-Asia-Summit-20101.html
23rd - 24th August 2010 at the Loews Philadelphia Hotel in Philadelphia, PA [2964]
2nd Annual drug discovery: easing the bottleneck
By gathering together the foremost experts on issues such as compound management innovation and strategies, gene expression strategies, and other pertinent and debated topics we hope to open up a dialog which will lead to improved speed to market, increased profit margins, and most importantly: new and effective drugs and biotechnology.
Contact: Pete jackson
Email: marketing@opalevents.org
Website: http://www.opalevents.org/conferencehtml/2010/drug_discovery_easing_chemistry_bottleneck_2010/drug_discovery_easing_chemistry_bottleneck.php
23rd - 24th August 2010 in Costa Mesa, CA, USA [2915]
Good Clinical Practice for Medical Device Investigations
Contact: Michael Roberts
Telephone: 610-688-1708
Email: info@cfpie.com
Website: http://www.cfpie.com/showitem.aspx?productid=122&source=pharmacy
23rd - 24th August 2010 in King of Prussia, PA, USA [2916]
Pharmaceutical and Biopharmaceutical Quality Control Laboratories - A Regulatory Compliance Primer
Contact: Michael Roberts
Telephone: 610-688-1708
Email: info@cfpie.com
Website: http://www.cfpie.com/showitem.aspx?productid=097&source=pharmacy
25th August 2010 at the Online Event in Palo Alto, USA [3088]
Process Validation for Drugs and Biologics
In this Process Validation training learn how to validate a manufacturing process and do it in a reasonable time.
Contact: admin
Telephone: +1-650-620-3915; Fax: +1-650-963-2556
Email: admin@complianceonline.com
Website: http://www.complianceonline.com/ecommerce/control/trainingFocus/~product_id=701628?channel=pharmorg
25th - 27th August 2010 in King of Prussia, PA, USA [2917]
cGMP Quality Principles for Pharmaceuticals, Biopharmaceuticals, Biologics and Medical Devices
Contact: Michael Roberts
Telephone: 610-688-1708
Email: info@cfpie.com
Website: http://www.cfpie.com/showitem.aspx?productid=095&source=pharmacy
25th - 26th August 2010 in Costa Mesa, CA, USA [2918]
Good Clinical Practice Auditing
Contact: Michael Roberts
Telephone: 610-688-1708
Email: info@cfpie.com
Website: http://www.cfpie.com/showitem.aspx?productid=121&source=pharmacy
30th August 2010 at the Online Event in Palo Alto,CA, USA [3089]
2010 Changes to the EU Variation Rules, Classifications and Submittal Requirements
This European Regulatory webinar is designed to provide an overview on the changes to the variation rules, classifications and filing requirements for all active pharmaceutical, biologics and orphan drug licenses in the EU.
Contact: admin
Telephone: +1-650-620-3915; Fax: +1-650-963-2556
Email: admin@complianceonline.com
Website: http://www.complianceonline.com/ecommerce/control/trainingFocus/~product_id=701739?channel=pharmorg
30th - 31st August 2010 in Costa Mesa, CA, USA [2919]
Detecting Fraud and Misconduct in Clinical Trials
Contact: Michael Roberts
Telephone: 610-688-1708
Email: info@cfpie.com
Website: http://www.cfpie.com/showitem.aspx?productid=117&source=pharmacy
31st August 2010 at the Online Event in Palo Alto,CA, USA [3090]
Streamline Documentation System in Pharmaceutical Laboratory
This laboratory documentation training Webinar will discuss the GMP requirements on laboratory records and how to streamline documentation system.
Contact: admin
Telephone: +1-650-620-3915; Fax: +1-650-963-2556
Email: admin@complianceonline.com
Website: http://www.complianceonline.com/ecommerce/control/trainingFocus/~product_id=701677?channel=pharmorg
2nd - 3rd September 2010 at the Maritim Hotel München in Munich, Germany [2870]
Introduction to Quantitative Pharmacology and PK/PD for Drug Discovery & Development Scientists
Contact: Annica Flodin
Email: annica.flodin@lakemedelsakademin.se
Website: http://www.lakemedelsakademin.se/templates/kurs/kurstillfalle.aspx?kId=3224&id=3819
8th - 9th September 2010 at the Amsterdam in Amsterdam, The Netherlands [2871]
Pharmaceutical Distribution 2010
Pharmaceutical Distribution 2010 was specifically researched and organized for professionals in the pharmaceutical industry who are looking to optimize their supply chain and distribution network to reduce costs and improve efficiency.
Contact: Smitha Chunduri
Email: enquire@iqpc.co.uk
Website: http://www.iqpc.com/Event.aspx?id=318130
8th September 2010 at the Online Event in Palo Alto,CA, USA [3091]
Engineering and Laboratory Mythology with Water System
This water systems webinar training will discuss the myths surrounding microbial monitoring and control approaches and alert you to the pitfalls of believing these myths which could cause over-confidence in a system’s design for microbial control or the suitability of your microbial test methods.
Contact: admin
Telephone: +1-650-620-3915; Fax: +1-650-963-2556
Email: admin@complianceonline.com
Website: http://www.complianceonline.com/ecommerce/control/trainingFocus/~product_id=701477?channel=pharmorg
8th - 10th September 2010 in Costa Mesa, CA, USA [2920]
Technical Writing for Pharmaceutical, Medical Device and Biotech Industries
Contact: Michael Roberts
Telephone: 610-688-1708
Email: info@cfpie.com
Website: http://www.cfpie.com/showitem.aspx?productid=077&source=pharmacy
8th - 10th September 2010 in Costa Mesa, CA, USA [2921]
Introduction to Molecular Biology Techniques
Contact: Michael Roberts
Telephone: 610-688-1708
Email: info@cfpie.com
Website: http://www.cfpie.com/showitem.aspx?productid=051&source=pharmacy
8th September 2010 at the Online Event in Palo Alto,CA, USA [3120]
How do I keep FDA happy with my contract manufacturer?
This Quality System Regulation training we will review the sections of Quality system regulations, design control regulations which FDA uses as an inspection tool. Actual FDA investigator training methods related to design control inspections. Real life examples of FDA design control compliance issues will be examined.
Contact: admin
Telephone: +1-650-620-3915; Fax: +1-650-963-2556
Email: admin@complianceonline.com
Website: http://www.complianceonline.com/ecommerce/control/trainingFocus/~product_id=701444?channel=pharmorg
9th September 2010 at the Online Event in Palo Alto,CA, USA [3106]
Controlling Change to meet GMP Requirements
This change control webinar will discuss the change control activities and documentation required to meet GMP requirements.
This webinar will provide valuable assistance to all regulated companies in evaluating their existing or anticipated change control activities and documentation requirements, especially in light of the changes in the FDA\\\'s stance vis a vis industry compliance and past problems.
Contact: admin
Telephone: +1-650-620-3915; Fax: +1-650-963-2556
Email: admin@complianceonline.com
Website: http://www.complianceonline.com/ecommerce/control/trainingFocus/~product_id=701741?channel=pharmorg
9th - 11th September 2010 at the Sånga-Säby in Stockholm, Sweden [2882]
Rosenon meeting on
Optimizing Drug Delivery to the Target
This year’s meeting will deal with various aspects of drug delivery both from a DMPK and a biopharmaceutical point of view.
Contact: Jenny Hagberg
Telephone: +46 8 723 50 08; Fax: +46 8 20 55 11
Email: jenny.hagberg@lakemedelsakademin.se
Website: http://www.lakemedelsakademin.se/ros
9th - 10th September 2010 in Costa Mesa, CA, USA [2922]
Preparing the CMC Section for NDAs/CTDs/INDs
Contact: Michael Roberts
Telephone: 610-688-1708
Email: info@cfpie.com
Website: http://www.cfpie.com/showitem.aspx?productid=061&source=pharmacy
9th September 2010 at the Online Event in Palo Alto,CA, USA [3092]
Key Factors to Write an Effective Standard Operating Procedure (SOP)
In this Effective Standard Operating Procedure (SOP) training learn how to develop a comprehensive, consistent SOP. The critical elements of a SOP which is easier to understand follow and review by operating personnel.
Contact: admin
Telephone: +1-650-620-3915; Fax: +1-650-963-2556
Email: admin@complianceonline.com
Website: http://www.complianceonline.com/ecommerce/control/trainingFocus/~product_id=701674?channel=pharmorg
9th September 2010 at the Online Event in Palo Alto, USA [3121]
Developing Supplier Quality Auditor Training Programs
In this webinar our expert trainer Jeff Kasoff will explain the best way to identify which employees can be the most effective auditors and how to train them.
Contact: admin
Telephone: +1-650-620-3915; Fax: +1-650-963-2556
Email: admin@complianceonline.com
Website: http://www.complianceonline.com/ecommerce/control/trainingFocus/~product_id=701569?channel=pharmorg
12th - 14th September 2010 at the Baltimore Marriott Waterfront in Baltimore, MD, USA [2859]
39th Annual Meeting of the American College of Clinical Pharmacology
2010 Topics for this meeting include: Managing the Changing Horizons of Drug Development - Clinical Pharmacologists as Leaders; Pharmacogenomic and Genetic Variation in Different Geographic Regions; Should Nutritional Supplements Be Regulated As Drugs?; Finding the Way Forward: Conducting International Pediatric Clinical Trials; Formulation, Quality, and Safety of Drugs in a Global Marketplace; The Health Benefits of Genomics; Model-based Drug Development: Fantasy or Future?
Contact: Susan Ulrich
Telephone: 315-768-6117; Fax: 315-768-6119
Email: SUE@ACCP1.org
Website: http://www.ACCP1.org
13th - 14th September 2010 at the Radisson SAS, Paris Boulogne in Paris, France [2831]
Clinical Statistics for Nonstatisticians
This course is designed to be an introduction of basic statistical concepts fundamental to clinical research, for professionals who have regular exposure to statistics either through studies or professional experience. The material is roughly equivalent to an introductory statistics course. While it includes a few formulae for individuals who are interested in computational details, the course emphasizes the application of statistical concepts to clinical investigation.
Event Code:
10542
Contact: DIA Europe
Telephone: 41 61 225 51 51
Email: DIAEUROPE@DIAEUROPE.ORG
Website: http://www.diahome.org/DIAHOME/Education/FindEducationalOffering.aspx?productID=21380&eventType=Training%20Course
13th - 16th September 2010 in India, India [2800]
World Pharma Trials Asia 2010
World Pharma Trials Asia is the only Asia-focused event in China in 2010, where the World’s Top Pharmas, biotechs, CROs, and regulators convene to provide the most comprehensive knowledge into the best operational strategies and practices in fast-tracking clinical drug development in Asia.
Contact: Esther Chan
Telephone: +65 6322 2742
Email: esther.chan@terrapinn.com
Website: http://www.terrapinn.com/2010/pharmatrialscn/
13th - 14th September 2010 at the SAS Radisson Hotel Boulogne in Boulogne-Billancourt (Paris) , France [2830]
Medical Approach in Diagnosis and Management of ADRs
The 17th edition of this annual training course, considered by many experts as one of the pillars of medical training in pharmacovigilance, focuses on how to use the medical knowledge in the diagnosis and management of selected Adverse Drug Reactions (ADRs).
Event Code:
10531
Contact: DIA Europe
Telephone: 41 61 225 51 51
Email: DIAEUROPE@DIAEUROPE.ORG
Website: http://www.diahome.org/DIAHOME/Education/FindEducationalOffering.aspx?productID=21363&eventType=Training%20Course
13th - 17th September 2010 at the Devils Head Resort in Merrimac, WI, USA [2634]
Thirteenth Annual Land O’Lakes Conference on Drug Metabolism/Applied Pharmacokinetics
The purpose of this University of Wisconsin School of Pharmacy conference is to provide an educational forum to discuss the current issues in selecting potential new therapeutic entities for drug development and current issues in drug metabolism, drug transport, pharmacokinetics, and pharmacodynamics.
Contact: James E. De Muth
Telephone: (608) 262-2422; Fax: (608) 262-2431
Email: jedemuth@pharmacy.wisc.edu
Website: http://www.pharmacy.wisc.edu/esp/drugmetabolismconference
13th - 15th September 2010 at the Drug Information Association, Inc. in Horsham, PA , USA [2832]
Regulatory Affairs Part I: The IND Phase
All You Need to know about IND Submissions in Only 3 Days
Event Code:
10456
Contact: Susan Mazak
Telephone: 215-442-6183
Email: Susan.Mazak@diahome.org
Website: http://www.diahome.org/DIAHOME/Education/FindEducationalOffering.aspx?productID=21494&eventType=Training%20Course
14th September 2010 at the Online Event in Palo Alto,CA, USA [3107]
Developing an ethylene oxide (EO) sterilization process for a product with limitations
This EO sterilization training Webinar will discuss how to modify EO sterilization process for complicated medical products which are sensitive to moisture, temperature, vacuum changes.
This presentation will address the various modifications that can be made to the EO process to accomplish this goal and the impact of those modifications.
Contact: admin
Telephone: +1-650-620-3915; Fax: +1-650-963-2556
Email: admin@complianceonline.com
Website: http://www.complianceonline.com/ecommerce/control/trainingFocus/~product_id=701680?channel=pharmorg
14th September 2010 at the Online Event in Palo Alto,CA, USA [3093]
The role of Analytical Program to Support Drug Development Process
This drug development process training Webinar will give an overview of drug development process, the regulatory requirements and the analytical technology used for pharmaceutical analysis supporting R & D.
Contact: admin
Telephone: +1-650-620-3915; Fax: +1-650-963-2556
Email: admin@complianceonline.com
Website: http://www.complianceonline.com/ecommerce/control/trainingFocus/~product_id=701667?channel=pharmorg
15th - 16th September 2010 in Costa Mesa, CA, USA [2923]
Medical Devices - EU Directives, Guidance, CE Marking and ISO Standard Certifications
Contact: Michael Roberts
Telephone: 610-688-1708
Email: info@cfpie.com
Website: http://www.cfpie.com/showitem.aspx?productid=092&source=pharmacy
15th - 16th September 2010 in King of Prussia, PA, USA [2924]
Financial Fundamentals for Non-Financial Personnel - How Financial Issues Impact Business
Contact: Michael Roberts
Telephone: 610-688-1708
Email: info@cfpie.com
Website: http://www.cfpie.com/showitem.aspx?productid=036&source=pharmacy
15th - 17th September 2010 in King of Prussia, PA, USA [2925]
ADME, PK/TK, and Drug Metabolism in Drug Discovery and Development
Contact: Michael Roberts
Telephone: 610-688-1708
Email: info@cfpie.com
Website: http://www.cfpie.com/showitem.aspx?productid=090&source=pharmacy
16th September 2010 at the Online Event in Palo Alto,CA, USA [3112]
Navigating Pediatric Trials from recruitment to successful on-time completion
In this Pediatric Trials training learn how to evaluate the current issues and best practices in pediatric drug development, clinical investigation of medicinal products and non clinical evaluation of pediatric drug products.
Contact: admin
Telephone: +1-650-620-3915; Fax: +1-650-963-2556
Email: admin@complianceonline.com
Website: http://www.complianceonline.com/ecommerce/control/trainingFocus/~product_id=701675?channel=pharmorg
16th - 17th September 2010 in Berlin, Germany [2926]
Pharmaceutical Production Batch Record Review
Contact: Michael Roberts
Telephone: 610-688-1708
Email: info@cfpie.com
Website: http://www.cfpie.com/showitem.aspx?productid=058&source=pharmacy
16th - 17th September 2010 in Dublin, Ireland [2927]
Analytical Method Validation for Biologics, Biopharmaceuticals and Other Therapeutic Products
Contact: Michael Roberts
Telephone: 610-688-1708
Email: info@cfpie.com
Website: http://www.cfpie.com/showitem.aspx?productid=096&source=pharmacy
16th September 2010 at the Online Event in Palo Alto,CA, USA [3108]
Medical Devices in the EU: CE Mark and 93/42/EEC Directive
This webinar will provide valuable assistance and guidance to all regulated companies that are preparing for CE Mark and ensuring compliance to MDD 93/42/EEC.
Contact: admin
Telephone: +1-650-620-3915; Fax: +1-650-963-2556
Email: admin@complianceonline.com
Website: http://www.complianceonline.com/ecommerce/control/trainingFocus/~product_id=700745?channel=pharmorg
17th - 19th September 2010 at the Hotel Holiday Inn in Mumbai,, India [3052]
Quality of Active Pharmaceutical Ingredients
This conference is organized in cooperation with World Health Organization (WHO), The European Directorate for the Quality of Medicine & Health Care (EDQM) and Drug Information Association (DIA). The major focus of this conference will be on the current regulatory requirements for the quality of API, Compliance with GMP Standards from Global Regulatory Authorities Perspective.
Event Code:
10658
Contact: Fahd Khan
Telephone: 91-9223267327
Email: Fahd.Khan@diaindia.org
Website: http://www.diahome.org/DIAHome/Education/FindEducationalOffering.aspx?productID=23922&eventType=Meeting
17th September 2010 at the Online Event in Palo Alto,CA, USA [3094]
Forced Degradation Studies - Biologics Stability Programs for Biopharmaceuticals
This training on Forced Degradation study on a Protein Therapeutic will discuss on the Forced Degradation Studies required for Well Characterized Protein Therapeutic products and how to leverage forced degradation results to design stability studies for Drug substances.
Contact: admin
Telephone: +1-650-620-3915; Fax: +1-650-963-2556
Email: admin@complianceonline.com
Website: http://www.complianceonline.com/ecommerce/control/trainingFocus/~product_id=701748?channel=pharmorg
20th - 22nd September 2010 at the Drug Information Association, Inc. in Horsham, PA, USA [2833]
Drug Safety Surveillance and Epidemiology
Learn the Practical Side of U.S. and International Safety Surveillance
Participate in discussion on ways to apply the role of epidemiology and risk management, from both industry and FDA perspectives.
Event Code:
10453
Contact: Colleen Buckley
Telephone: 215-442-6108
Email: Colleen.Buckley@diahome.org
Website: http://www.diahome.org/DIAHOME/Education/FindEducationalOffering.aspx?productID=21728&eventType=Training%20Course
20th - 21st September 2010 in King of Prussia, PA, USA [2928]
Clinical Document Management – A Trial by Trial Approach to Compliance
Contact: Michael Roberts
Telephone: 610-688-1708
Email: info@cfpie.com
Website: http://www.cfpie.com/showitem.aspx?productid=124&source=pharmacy
20th - 22nd September 2010 in Dublin, Ireland [2929]
CMC Regulatory Compliance for Biopharmaceuticals and Biologics
Contact: Michael Roberts
Telephone: 610-688-1708
Email: info@cfpie.com
Website: http://www.cfpie.com/showitem.aspx?productid=017&source=pharmacy
20th - 21st September 2010 in Costa Mesa, CA, USA [2930]
Labeling and Labeling Controls for Medical Devices
Contact: Michael Roberts
Telephone: 610-688-1708
Email: info@cfpie.com
Website: http://www.cfpie.com/showitem.aspx?productid=106&source=pharmacy
20th - 21st September 2010 in Dublin, Ireland [2931]
Validation of Computer Systems
Contact: Michael Roberts
Telephone: 610-688-1708
Email: info@cfpie.com
Website: http://www.cfpie.com/showitem.aspx?productid=081&source=pharmacy
20th - 21st September 2010 at the Oriel College, University of Oxford in Oxford, UK [2981]
First International ‘EGM: European Genomics-2010- Meeting’ On ‘Genotyping, SNiPs to Traits & Diseases’
“A Unique Theme to Combine Genomics with Disease Biology”
Keytopics:
Genomic Studies in plants and animal model Polymorphisms & Human Trait Genes
SNP Hybrid Arrays & Mapping Studies
Copy Number & Structural Variations
Genome Variation & Allele-specific Gene Expression, Haplotype Mapping & Variome Projects
Comparative Genomic hybridization
Global Variation in the human Genome & Disease
Contact: Dr Krishnarao Appasani
Telephone: 781-891-8181; Fax: 781-891-8234
Email: Genexpsys@expressgenes.com
Website: http://www.expressgenes.com
20th - 21st September 2010 at the Oriel College, University of Oxford in Oxford, United Kingdom [2982]
First International ‘END: European Neurodegenerative Diseases-2010-Meeting’ On ‘Biology to Drugs & Therapeutics’
Keywords: Neural Plasticity, Brain Disorders, Alzheimer’s disease, Parkinson disease, ALS, Dyslexia, Huntington’s disease, Autism, clinical trials Novel therapeutics, Imaging
“A Unique Theme to Combine Neurobiology, Memory & Diseases”
Contact: Dr Krishnarao Appasani
Telephone: 781-891-8181; Fax: 781-891-8234
Email: Genexpsys@expressgenes.com
Website: http://www.expressgenes.com
20th - 23rd September 2010 at the Pennsylvania Convention Center in Philadelphia, USA [3076]
8th Cold Chain Distribution for Pharmaceuticals Global Forum
Pharma IQ’s 8th Cold Chain Distribution for Pharmaceutical Global Forum provides pharmaceutical supply chain professionals the resources to update their supply chain with industry best practices. This year’s event will show how to internationally distribute medicines safely in compliance with global regulatory standards. Audience includes: Supply chain operations and logistics, pharmacy operations, packaging and labeling, manufacturing, data managers and 3PL providers
Contact: Abby Lombardi
Telephone: 1-800-882-8684
Email: abby.lombardi@iqpc.com
Website: http://www.coldchainpharma.com
21st - 22nd September 2010 at the Hilton Parsippany Hotel in Parsippany, NJ, USA [2823]
Pharma CI Conference & Exhibition
The Pharma CI Conference & Exhibition is the largest and best gathering of senior level pharma, biotech, medical device, and diagnostic executives in competitive/business intelligence.
Contact: Amy Yueh
Telephone: 212-228-7974
Email: info@pharmaciconference.com
Website: http://www.pharmaciconference.com
21st September 2010 at the Online Event in Palo Alto,CA, USA [3113]
What are the “Good Clinical Practices” (GCP) of Research involving Human Subjects
In this GCP webinar understand The Regulatory requirements to follow to be GCP compliant for a site involved in research involving human subjects.
Contact: admin
Telephone: +1-650-620-3915; Fax: +1-650-963-2556
Email: admin@complianceonline.com
Website: http://www.complianceonline.com/ecommerce/control/trainingFocus/~product_id=701726?channel=pharmorg
21st September 2010 at the Online Event in Palo Alto,CA, USA [3109]
Medical Device Changes and The 510(k)
This 510(k) webinar training will discuss how to do a meaningful result drive 510(k)/change analysis activity so as to satisfy FDA requirements.
Contact: admin
Telephone: +1-650-620-3915; Fax: +1-650-963-2556
Email: admin@complianceonline.com
Website: http://www.complianceonline.com/ecommerce/control/trainingFocus/~product_id=701742?channel=pharmorg
21st - 22nd September 2010 in King of Prussia, PA, USA [2932]
Introduction to Medical Device Submissions – 510ks, PMAs, and Exemptions
Contact: Michael Roberts
Telephone: 610-688-1708
Email: info@cfpie.com
Website: http://www.cfpie.com/showitem.aspx?productid=127&source=pharmacy
21st - 22nd September 2010 in King of Prussia, PA, USA [2933]
Preparation of FDA Submissions (INDs, NDAs, BLAs, ANDAs, Post-Approval Supplements) and Communicating with the FDA
Contact: Michael Roberts
Telephone: 610-688-1708
Email: info@cfpie.com
Website: http://www.cfpie.com/showitem.aspx?productid=085&source=pharmacy
21st - 22nd September 2010 at the Hilton Garden Inn in Philadelphia, USA, Canada [2955]
The International API GMP Guidance: ICH Q7 Implementation and Application
Addressing Issues on Regulatory Requirements, Guidelines and Practical Approaches to API’s Manufacturing
This comprehensive 2-day program was developed along with FDA to train both regulatory (FDA) and Industry personnel. It was written by members of the ICH Q7A Expert Work Group and designed to teach both the meaning and intent of the API GMP.
Contact: Rebecca Tan
Telephone: 416.410.7402; Fax: 905.472.1819
Email: enquiry@ipacanada.com
Website: http://www.ipacanada.com/viewcourse.php?id=ichq0910ph
21st September 2010 at the Reggie Lewis Track & Athletic Center in Boston, MA, United States [2979]
BioPharmaPM: Delivering Value Through Projects
Leaders from top Life Science companies will share learnings and best practices for program and project success in the Pharmaceutical, Medical Device, and Biotech industries. Attendees will gain insight into practical and proactive techniques for building and executing effective program and project plans, including how to overcome some of the toughest challenges in building and maintaining a realistic schedule under pressure, and delivering a quality product to market.
Contact: Jan Wells
Email: bppmboston@biopharmapm.org
Website: http://www.mscholar.com/bppmboston
22nd - 24th September 2010 at the Ramada Plaza Basel in Basel, Switzerland [2835]
Clinical Project Management in Europe - Part I
This course provides a comprehensive foundation in clinical project management. Using the Project Management Body of Knowledge (PMBOK®) as a guide, participants will be taught how to apply project management strategies, tools and techniques to their clinical trial projects.
Contact: DIA Europe
Telephone: 41 61 22 55 151
Email: DIAEUROPE@DIAEUROPE.ORG
Website: http://www.diahome.org/DIAHOME/Education/FindEducationalOffering.aspx?productID=21729&eventType=Training%20Course
22nd September 2010 at the Online Event in Palo Alto,CA, USA [3114]
The ICF Process: Tips on Achieving Optimal compliance and Comprehension
This ICF process Webinar training teaches how to create an informed consent process for achieving optimal site compliance and subject comprehension. It also discusses how an inadequate ICF can affect data integrity and patient safety and/or well-being.
Contact: admin
Telephone: +1-650-620-3915; Fax: +1-650-963-2556
Email: admin@complianceonline.com
Website: http://www.complianceonline.com/ecommerce/control/trainingFocus/~product_id=701686?channel=pharmorg
22nd - 23rd September 2010 in Costa Mesa, CA, USA [2934]
Software Development for Medical Device Professionals
Contact: Michael Roberts
Telephone: 610-688-1708
Email: info@cfpie.com
Website: http://www.cfpie.com/showitem.aspx?productid=071&source=pharmacy
22nd - 23rd September 2010 in Costa Mesa, CA, USA [2935]
Purchasing Controls in the Medical Device Industry
Contact: Michael Roberts
Telephone: 610-688-1708
Email: info@cfpie.com
Website: http://www.cfpie.com/showitem.aspx?productid=119&source=pharmacy
22nd - 24th September 2010 in Dublin, Ireland [2936]
Technical Writing for Pharmaceutical, Medical Device and Biotech Industries
Contact: Michael Roberts
Telephone: 610-688-1708
Email: info@cfpie.com
Website: http://www.cfpie.com/showitem.aspx?productid=077&source=pharmacy
22nd September 2010 at the Online Event in Palo Alto,CA, USA [3095]
Stability Program to support Shipping and Distribution of Drug Products
Learn key factors affecting shipping and distribution of product and the stability studies that should be done to support shipping and distribution.
Contact: admin
Telephone: +1-650-620-3915; Fax: +1-650-963-2556
Email: admin@complianceonline.com
Website: http://www.complianceonline.com/ecommerce/control/trainingFocus/~product_id=701678?channel=pharmorg
22nd September 2010 at the Online Event in Palo Alto,CA, USA [3096]
The Hero of Manufacturing Contamination Control -- The Microbiology Lab
This webinar on Contamination Control will discuss, how the micro lab can be more effectively utilized to prevent or head off microbial contamination issues as well as effectively resolve problems like recurring micro failures, investigations, and ineffective CAPAs.
Contact: admin
Telephone: +1-650-620-3915; Fax: +1-650-963-2556
Email: admin@complianceonline.com
Website: http://www.complianceonline.com/ecommerce/control/trainingFocus/~product_id=701478?channel=pharmorg
23rd - 24th September 2010 at the Ramada Plaza Basel in Basel, Switzerland [2836]
Building the eCTD: Practical Solutions to Compile Electronic Submissions
This course will offer insight into the compilation of the eCTD, share experience and best practise gained during eCTD submissions in the EU, and the eCTD review process. The focus will be on practical experience gained in preparing and submitting electronically.
Event Code:
10545
Contact: DIA Europe
Telephone: 41 61 225 51 51
Email: DIAEUROPE@DIAEUROPE.ORG
Website: http://www.diahome.org/DIAHOME/Education/FindEducationalOffering.aspx?productID=21648&eventType=Training%20Course
23rd - 24th September 2010 in King of Prussia, PA, USA [2937]
Stability Programs for Product Shelf Life - From Development to Approval
Contact: Michael Roberts
Telephone: 610-688-1708
Email: info@cfpie.com
Website: http://www.cfpie.com/showitem.aspx?productid=072&source=pharmacy
23rd - 24th September 2010 in King of Prussia, PA, USA [2938]
Best Practices for Facilities and Utilities Design, Qualification and Monitoring
Contact: Michael Roberts
Telephone: 610-688-1708
Email: info@cfpie.com
Website: http://www.cfpie.com/showitem.aspx?productid=008&source=pharmacy
23rd - 24th September 2010 in King of Prussia, PA, USA [2939]
Introduction to Medical Combination Products
Contact: Michael Roberts
Telephone: 610-688-1708
Email: info@cfpie.com
Website: http://www.cfpie.com/showitem.aspx?productid=126&source=pharmacy
26th - 30th September 2010 at the Universo Hotel in Rome, Italy [2869]
The 17th Intermediate Workshop on PK/PD Data Analysis: A four-day Course Using WinNonlin
Contact: Annica Flodin
Email: annica.flodin@lakemedelsakademin.se
Website: http://www.lakemedelsakademin.se/templates/kurs/kurstillfalle.aspx?kId=3258&id=3820
27th - 28th September 2010 at the Drug Information Association, Inc. in Horsham, PA, USA [2841]
Clinical Statistics for Nonstatisticians
Fundamentals of Statistics for Clinical Research Professionals
Learn the basic statistical concepts fundamental to clinical research, including how to apply statistical concepts to clinical investigation
Event Code:
10410
Contact: Susan Mazak
Telephone: 215-442-6183
Email: Susan.Mazak@diahome.org
Website: http://www.diahome.org/DIAHOME/Education/FindEducationalOffering.aspx?productID=21390&eventType=Training%20Course
27th - 29th September 2010 at the Hotel Austria Trend Savoyen in Vienna, Austria [2712]
Workshop on Statistical Methodology in Clinical R&D
A 2 ½ day workshop examining the ever important role of statistics in clinical R&D and new applications of statistical methods
Contact: DIA EUROPE
Email: DIAEUROPE@DIAEUROPE.ORG
Website: http://www.diahome.org/DIAHOME/Education/FindEducationalOffering.aspx?productID=22706&eventType=Meeting
27th - 28th September 2010 in King of Prussia, PA, USA [2940]
Good Laboratory Practices (GLP) for Pre-Clinical Testing
Contact: Michael Roberts
Telephone: 610-688-1708
Email: info@cfpie.com
Website: http://www.cfpie.com/showitem.aspx?productid=112&source=pharmacy
27th - 28th September 2010 in King of Prussia, PA [2941]
Best Practices for an Effective Cleaning Validation Program
Contact: Michael Roberts
Telephone: 610-688-1708
Email: info@cfpie.com
Website: http://www.cfpie.com/showitem.aspx?productid=007&source=pharmacy
27th - 28th September 2010 in Dublin, Ireland [2942]
Writing Effective Standard Operating Procedures and Other Process Documents
Contact: Michael Roberts
Telephone: 610-688-1708
Email: info@cfpie.com
Website: http://www.cfpie.com/showitem.aspx?productid=083&source=pharmacy
27th - 28th September 2010 in Dublin, Ireland [2943]
Adverse Drug Events – Reporting & Regulatory Requirements
Contact: Michael Roberts
Telephone: 610-688-1708
Email: info@cfpie.com
Website: http://www.cfpie.com/showitem.aspx?productid=002&source=pharmacy
27th - 28th September 2010 in Dublin, Ireland [2944]
Design Control for Medical Device Professionals
Contact: Michael Roberts
Telephone: 610-688-1708
Email: info@cfpie.com
Website: http://www.cfpie.com/showitem.aspx?productid=024&source=pharmacy
28th September 2010 at the Online Event in Palo Alto,CA, USA [3110]
Validating Radiation Sterilization for medical device industries
This Radiation sterilization training will discuss how radiation sterilization works, the equipment involved, major issues with product sterilization via radiation, and the validation requirements. Routine process control and monitoring will be reviewed along with requirements to maintain the process effectiveness.
Contact: admin
Telephone: +1-650-620-3915; Fax: +1-650-963-2556
Email: admin@complianceonline.com
Website: http://www.complianceonline.com/ecommerce/control/trainingFocus/~product_id=701604?channel=pharmorg
28th - 29th September 2010 in King of Prussia, PA, USA [2945]
The EU Clinical Trial Directive
Contact: Michael Roberts
Telephone: 610-688-1708
Email: info@cfpie.com
Website: http://www.cfpie.com/showitem.aspx?productid=030&source=pharmacy
28th - 30th September 2010 at the De Vere Venues Canary Wharf in London, UK [3078]
Joint EFGCP Children\\\'s Medicine Working Party 6th Annual Conference and DIA 4th Paediatric Forum
The conference will include three parallel breakout sessions on each day for a lively interactive discussion. Furthermore, it will provide participants with the opportunity to ask questions by e-mail before the conference and during the morning of day 1. These will be addressed in the afternoon by a speaker panel chaired by Paolo Tomasi, European Medicines Agency (EMA).
Event Code:
10118
Contact: NA
Telephone: 32 2 732 87 83
Email: CONFERENCES@EFGCP.BE
Website: http://www.diahome.org/DIAHome/Education/FindEducationalOffering.aspx?productID=23618&eventType=Meeting
28th September 2010 at the Online Event in Palo Alto,CA, USA [3115]
How to Use Foreign Trial Data in Your NDA Approval Process
In this NDA Approval Process training Webinar learn the guidance and regulations governing FDA’s acceptance of foreign trial data and know how FDA implementing these rule along with design considerations and requirements for foreign trials.
Contact: admin
Telephone: +1-650-620-3915; Fax: +1-650-963-2556
Email: admin@complianceonline.com
Website: http://www.complianceonline.com/ecommerce/control/trainingFocus/~product_id=701671?channel=pharmorg
29th - 30th September 2010 at the Drug Information Association, Inc. in Horsham, PA, USA [2842]
Advanced Clinical Statistics for Non-Statisticians
This course answers common questions and addresses topics such as modeling, multiplicity adjustments, noninferiority, data mining, adaptive designs, Bayesian principles, and survival methods. This course will increase the level of statistical knowledge of nonstatisticians so that collaborative efforts of statisticians and nonstatisticians on clinical investigative teams can be improved
Contact: Susan Mazak
Telephone: 215-442-6183
Email: Susan.Mazak@diahome.org
Website: http://www.diahome.org/DIAHOME/Education/FindEducationalOffering.aspx?productID=21391&eventType=Training%20Course
29th September - 1st October 2010 in King of Prussia, PA, USA [2946]
Good Manufacturing Practices
Contact: Michael Roberts
Telephone: 610-688-1708
Email: info@cfpie.com
Website: http://www.cfpie.com/showitem.aspx?productid=113&source=pharmacy
29th September - 1st October 2010 in Dublin, Ireland [2947]
The Drug Development Process - From Discovery to Commercialization
Contact: Michael Roberts
Telephone: 610-688-1708
Email: info@cfpie.com
Website: http://www.cfpie.com/showitem.aspx?productid=025
29th - 30th September 2010 in King of Prussia, PA, USA [2948]
Process Validation for Drugs and Biologics
Contact: Michael Roberts
Telephone: 610-688-1708
Email: info@cfpie.com
Website: http://www.cfpie.com/showitem.aspx?productid=049&source=pharmacy
29th - 30th September 2010 in Dublin, Ireland [2949]
Design Validation, Verification, and Risk Analysis for Medical Device Professional
Contact: Michael Roberts
Telephone: 610-688-1708
Email: info@cfpie.com
Website: http://www.cfpie.com/showitem.aspx?productid=118
29th September 2010 at the Online Event in Palo Alto,CA, USA [3116]
Ensuring GCP compliance through quality auditing in clinical trial
This clinical trial audit training reviews the key elements of quality auditing processes and correlates them to the ICH guidelines and applicable FDA regulations.
Contact: admin
Telephone: +1-650-620-3915; Fax: +1-650-963-2556
Email: admin@complianceonline.com
Website: http://www.complianceonline.com/ecommerce/control/trainingFocus/~product_id=701745?channel=pharmorg
29th September 2010 at the Online Event in Palo Alto,CA, USA [3118]
Critical Role of Quality Audit in GxP Compliance & Improvement
This Webinar will address the key elements on being an effective auditor for your company covering the different types of audits, what do audits measure and how are audit results measured and certainly why perform audits to begin with.
Contact: admin
Telephone: +1-650-620-3915; Fax: +1-650-963-2556
Email: admin@complianceonline.com
Website: http://www.complianceonline.com/ecommerce/control/trainingFocus/~product_id=700982?channel=pharmorg
30th September - 1st October 2010 at the Washington Marriott Hotel in Washington DC , USA [2884]
Global Approach to the Risk Management of Medicines
Join Authorities, Global Regulators, Industry Representatives, and
Marketing Application Holders for an Interactive Discussion of RMPS.
Contact: Ellen Diegel
Telephone: 215.442.6158
Email: Ellen.Diegel@diahome.org
Website: http://www.diahome.org/DIAHome/Education/FindEducationalOffering.aspx?productID=23726&eventType=Meeting
30th September - 1st October 2010 in King of Prussia, PA, USA [2950]
European Filing & Registration Procedures
Contact: Michael Roberts
Telephone: 610-688-1708
Email: info@cfpie.com
Website: http://www.cfpie.com/showitem.aspx?productid=031&source=pharmacy
30th September - 1st October 2010 in Dublin, Ireland [2951]
Effective Document Management for Pharmaceutical, Biotech, & Medical Device Industries
Contact: Michael Roberts
Telephone: 610-688-1708
Email: info@cfpie.com
Website: http://www.cfpie.com/showitem.aspx?productid=027&source=pharmacy
30th September 2010 at the Online Event in Palo Alto,CA, USA [3119]
Best Practices for Managing FDA Investigators and Handling FDA 483 Observations
In this course, you learn how to properly manage FDA during an inspection, how to impact the FDA decision-makers, and how to respond to FDA 483 Observations. In addition, the course will show you how to strategically address compliance issues and avoid a Warning Letter
Contact: admin
Telephone: +1-650-620-3915; Fax: +1-650-963-2556
Email: admin@complianceonline.com
Website: http://www.complianceonline.com/ecommerce/control/trainingFocus/~product_id=700294?channel=pharmorg
1st October 2010 at the De Vere Venues in London,, UK [2868]
Joint DIA/EFGCP Pharmacovigilance Audit and Inspection - Opportunities for Patient Safety
Please see our website for details
Contact: DIA Europe
Telephone: 41 61 225 51 51
Email: DIAEUROPE@DIAEUROPE.ORG
Website: http://www.diahome.org/DIAHOME/Education/FindEducationalOffering.aspx?productID=23321&eventType=Meeting
1st October 2010 at the Online Event in Palo Alto,CA, USA [3097]
GMPs in Biopharmaceutical Development Laboratories
This GMP webinar training on Biopharmaceutical lab provides the attendee with an overview of the GMPs as they pertain to early phase development labs. This course satisfies the annual mandatory training required for personnel employed in GMP laboratories.
Contact: admin
Telephone: +1-650-620-3915; Fax: +1-650-963-2556
Email: admin@complianceonline.com
Website: http://www.complianceonline.com/ecommerce/control/trainingFocus/~product_id=701749?channel=pharmorg
4th - 5th October 2010 in King of Prussia, PA [2987]
Practical Methods for Project Management
Contact: Michael Roberts
Telephone: 610-688-1708
Email: info@cfpie.com
Website: http://www.cfpie.com/showitem.aspx?productid=060&source=pharmacy
4th - 5th October 2010 in King of Prussia, PA [2988]
Patent and Other Intellectual Property Law for the Life Sciences Industry
Contact: Michael Roberts
Telephone: 610-688-1708
Email: info@cfpie.com
Website: http://www.cfpie.com/showitem.aspx?productid=048&source=pharmacy
4th - 6th October 2010 in Costa Mesa, CA [2989]
Tablets & Capsules - Development, Manufacture and Testing of Solid Oral Dosage Forms
Contact: Michael Roberts
Telephone: 610-688-1708
Email: info@cfpie.com
Website: http://www.cfpie.com/showitem.aspx?productid=120&source=pharmacy
4th - 5th October 2010 in Costa Mesa, CA, USA [2990]
Validation of Computer Systems
Contact: Michael Roberts
Telephone: 610-688-1708
Email: info@cfpie.com
Website: http://www.cfpie.com/showitem.aspx?productid=081&source=pharmacy
4th - 6th October 2010 at the Drug Information Association, Inc in Horsham, PA, USA [2845]
Regulatory Affairs Part II: The NDA Phase
Basics of NDA Submission and Post-marketing Regulatory Requirements
Contact: Susan Mazak
Telephone: 215-442-6183
Email: Susan.Mazak@diahome.org
Website: http://www.diahome.org/DIAHOME/Education/FindEducationalOffering.aspx?productID=21497&eventType=Training%20Course
4th - 8th October 2010 at the Pyle Center in Madison, WI, USA [2632]
Practical Strategies for Developing Preclinical and Phase 1 Oral Drug Formulations
This University of Wisconsin School of Pharmacy short course covers practical aspects of dosage form development for preclinical and phase 1 formulations. The formulation approaches include solubilization and disperse phase systems (suspensions, emulsions, microemulsions, liposomes and micelles) for preclinical as well as powders for reconstitution, capsules and tablets for phase 1.
Contact: James E. De Muth
Telephone: (608) 262-2422; Fax: (608) 262-2431
Email: jedemuth@pharmacy.wisc.edu
Website: http://www.pharmacy.wisc.edu/esp/drugdevelopment
4th - 7th October 2010 at the Pyle Center in Madison, WI, USA [2984]
Translational Biology: Pre-Clinical Strategies for Drug Development
Turning Pre-clinical Data into Clinical Strategy
This course will focus on moving promising new chemical entities (NCEs) and new biological entities (NBEs) from animal models to human subjects and the application of PK/PD models’ toxicity data and safety pharmacology towards the development of a strategic human clinical trial program. Handling and early avoidance of serious safety issues will also be addressed in the course.
Contact: Eric Buxton
Telephone: 608-265-2259; Fax: 608-262-2431
Email: ebuxton@pharmacy.wisc.edu
Website: http://ce.pharmacy.wisc.edu/courseinfo/2010TranslationalBiology/
5th - 6th October 2010 at the L’Enfant Plaza Hotel in Washington DC, USA [2957]
Development of Type 2 Diabetes Mellitus Drugs: State of the Art Cardiovascular Safety Assessments
Interact with Senior FDA Members to Explore Emerging Issues in Cardiovascular Safety and Diabetic Drug Development.
Event Code:
10035
CALL FOR ABSTRACTS
Please submit all abstracts via email to Rachel Minnick, Program Developer Rachel.Minnick@diahome.org
All abstracts must be received by August 17, 2010.
Please provide all information in PowerPoint or MSWord format
Contact: Rachel Minnick
Telephone: 215.442.6131
Email: Rachel.Minnick@diahome.org
Website: http://www.diahome.org/DIAHome/Education/FindEducationalOffering.aspx?productID=23808&eventType=Meeting
5th - 6th October 2010 in King of Prussia, PA, USA [2991]
Effective Quality Assurance Auditing for FDA Regulated Industries
Contact: Michael Roberts
Telephone: 610-688-1708
Email: info@cfpie.com
Website: http://www.cfpie.com/showitem.aspx?productid=028&source=pharmacy
5th - 6th October 2010 in Dublin, Ireland [2992]
The EU Clinical Trial Directive
Contact: Michael Roberts
Telephone: +1-610-688-1708
Email: info@cfpie.com
Website: http://www.cfpie.com/showitem.aspx?productid=030&source=pharmacy
5th - 6th October 2010 in Philadelphia, PA, USA [3080]
Analysis of Metal Impurities According to Proposed USP Chapters
The United State Pharmacopoeia, USP has significantly changed the way metal analysis in drugs and dietary supplements. In January 2010 USP proposed three new chapters on elemental impurities (<232>, <2232>, and <233>) with new requirements for limits and recommendations for analysis metal analysis in drugs and dietary ingredients.
Contact: Rebecca Tan
Telephone: 416.410.7402; Fax: 905.472.1819
Email: enquiry@ipacanada.com
Website: http://www.ipacanada.com/viewcourse.php?id=analysis1010ph
5th October 2010 at the Online Event in Palo Alto,CA, USA [3117]
The FDA Tripod - Clinical Trial Regulations, Compliance and GCP in Drug Development
This GCP training Webinar will discuss the principals of GCP, the regulations pertaining to it and elements necessary for FDA compliance.
Contact: admin
Telephone: +1-650-620-3915; Fax: +1-650-963-2556
Email: admin@complianceonline.com
Website: http://www.complianceonline.com/ecommerce/control/trainingFocus/~product_id=701676?channel=pharmorg
6th - 8th October 2010 at the Hilton Hotel in Prague, Czech Republic [3101]
Comprehensive Training on European Regulatory Affairs including Different Registration Procedures and Variations: Expert Overview
The ‘Comprehensive Training on European Regulatory Affairs including different Registration Procedures and Variations: Expert Overview’ training course is a key course developed by DIA in Europe. This course provides a comprehensive description and discussion of the regulatory environment. The course focuses on Europe but also looks at regulations in other regions including the USA and Japan.
Contact: DIA Europe
Telephone: 41 61 225 51 51
Email: DIAEUROPE@DIAEUROPE.ORG
Website: http://www.diahome.org/DIAHome/Education/FindEducationalOffering.aspx?productID=23851&eventType=Training%20Course
6th - 7th October 2010 at the Radisson Blu Arlandia Hotel at Arlanda airport in Stockholm, Sweden [3087]
2nd Clinical Trials in the Nordic Countries
A conference for professionals managing and/or coordinating clinical trials over the Nordic boarders who desire a broader understanding of requirements, processes and procedures. It will be an opportunity to meet colleagues and listen to regulatory authority representatives and key actors in the field.
Contact: Kia olsson
Telephone: +46 8 723 5051; Fax: +46 8 205511
Email: kia.olsson@lakemedelsakademin.se
Website: http://www.lakemedelsakademin.se/CTNordic
6th - 8th October 2010 at the Park Inn London, Russell Square in London, UK [2846]
Practical GCP Compliance Auditing of Trials & Systems
This GCP auditing course is designed to provide practical training resulting in a harmonised, common audit methodology in Europe. The ICH GCP guideline implemented in the EU, Japan and the USA is being widely incorporated into guidelines worldwide. Systems audits, previously seen as "advanced auditing", have become a basic task of many audit groups and are an essential element of inspections in Europe.
Contact: DIA Europe
Telephone: 41 61 225 51 51
Email: DIAEUROPE@DIAEUROPE.ORG
Website: http://www.diahome.org/DIAHOME/Education/FindEducationalOffering.aspx?productID=21873&eventType=Training%20Course
7th - 8th October 2010 in King of Prussia, PA, USA [2996]
Quality System Regulation for the Medical Device & Biotech Industries
Contact: Michael Roberts
Telephone: 610-688-1708
Email: info@cfpie.com
Website: http://www.cfpie.com/showitem.aspx?productid=066&source=pharmacy
7th - 8th October 2010 in Dublin, Ireland [2994]
European Filing & Registration Procedures
Contact: Michael Roberts
Telephone: 610-688-1708
Email: info@cfpie.com
Website: http://www.cfpie.com/showitem.aspx?productid=031&source=pharmacy
7th - 8th October 2010 in King of Prussia, PA, USA [2995]
How to Implement Risk Management Principles and Activities within a Quality Management System
Contact: Michael Roberts
Telephone: 610-688-1708
Email: info@cfpie.com
Website: http://www.cfpie.com/showitem.aspx?productid=041&source=pharmacy
7th - 8th October 2010 in King of Prussia, PA [2993]
Aseptic Processing in the Manufacture of Biotech and Pharmaceutical Products
Contact: Michael Roberts
Telephone: 610-688-1708
Email: info@cfpie.com
Website: http://www.cfpie.com/showitem.aspx?productid=005&source=pharmacy
7th - 8th October 2010 at the Drug Information Association, Inc. in Horsham, PA, USA [2847]
Utilizing Chemistry, Manufacturing & Control (CMC) in Drug Development
Arm yourself with the tools to write or assemble CMC sections of regulatory submission, to prepare for CMC meetings with FDA, and to avoid non-compliance.
Event Code:
10413
Contact: Susan Mazak
Telephone: 215-442-6183
Email: Susan.Mazak@diahome.org
Website: http://www.diahome.org/DIAHOME/Education/FindEducationalOffering.aspx?productID=21393&eventType=Training%20Course
7th October 2010 at the Park Inn London, Russell Square in London, UK [2848]
Introduction to Signal Detection and Data Mining in Pharmacovigilance
The World Health Organisation (WHO) defines the term Signal as “reported information on a possible causal relationship between an adverse event and drug, the relationship being unknown or incompletely documented previously”. Adverse Drug Reactions (ADRs) may be identified as Signals for clinical and / or quantitative reasons. This course will cover the fundamentals of classical and statistical signal detection and data mining in Pharmacovigilance.
Event Code:
10558
Contact: DIA Europe
Telephone: 41 61 225 51 51
Email: DIAEUROPE@DIAEUROPE.ORG
Website: http://www.diahome.org/DIAHOME/Education/FindEducationalOffering.aspx?productID=23402&eventType=Training%20Course
7th - 8th October 2010 at the Grand Copthorne Waterfront in Singapore, Singapore [3057]
3rd Pharma Marketing and Sales Strategies
Key themes and issues to be discussed include:
1) Changing Dynamics in Asian Pharmaceutical Markets
2)Focusing on Patient Outcomes to Drive Market Acceptance & Loyalty
3)Market Access & Reimbursement Practices
4)The Pharma Talent Management Dilemma in Asia
5)Building Dedicated Sales Teams to Increase Hospital Channel Sales
Contact: Rita Parasurum
Telephone: 6565082482
Email: rita.parasurum@ibcasia.com.sg
Website: http://www.ibc-asia.com/pharmamarketing
8th - 9th October 2010 at the Double Tree Hotel and Executive Meeting Center in Bethesda, MD, USA [2844]
Pediatric Research in the US: Are We There Yet?
Join Pediatric Research Experts to Share Solutions to the Challenges Involved in Constructing and Conducting Global Pediatric Programs.
Event Code:
10027
Contact: Constance Burnett
Telephone: 215.293.5800
Email: Constance.Burnett@diahome.org
Website: http://www.diahome.org/DIAHOME/Education/FindEducationalOffering.aspx?productID=23614&eventType=Meeting
8th October 2010 at the Park Inn London, Russell Square in London, UK [2849]
How to Prepare for Pharmacovigilance Audits and Inspections
Every pharmacovigilance function will, at one time or another, undergo governmental or health authority inspections as well as audits by license partners, internal auditors and others. The course will teach you how to prepare for an audit / inspection from the time of the receipt of the announcement (or of the arrival of the inspectors at your doorstep) to the conclusion of the audit or inspection.
Event Code:
10559
Contact: DIA Europe
Telephone: 41 61 225 51 51
Email: DIAEUROPE@DIAEUROPE.ORG
Website: http://www.diahome.org/DIAHOME/Education/FindEducationalOffering.aspx?productID=23404&eventType=Training%20Course
11th - 12th October 2010 in Dublin, Ireland [2999]
Medical Devices - EU Directives, Guidance, CE Marking and ISO Standard Certifications
Contact: Michael Roberts
Telephone: 610-688-1708
Email: info@cfpie.com
Website: http://www.cfpie.com/showitem.aspx?productid=092&source=pharmacy
11th - 13th October 2010 at the Lowell Center in Madison, WI, USA [2986]
Technical Writing in a Regulated Environment
Many times the more words we use to make our writing look eloquent, the more we detract from the meaning we intend. When a reader has to spend time studying your sentences to derive their meaning, precious time is wasted. Regardless of field of study or profession it is highly likely that you will have to do lots of communication via writing. The better your understanding of the basic principles of technical writing, the more effective you will be in your academic or professional career.
Contact: Eric Buxton
Telephone: 608-265-2259; Fax: 608-262-2431
Email: ebuxton@pharmacy.wisc.edu
Website: http://ce.pharmacy.wisc.edu/courseinfo/2010TechnicalWriting/
11th - 12th October 2010 in King of Prussia, PA, USA [2997]
FDA Inspections - What to Expect and How to Prepare
Contact: Michael Roberts
Telephone: 610-688-1708
Email: info@cfpie.com
Website: http://www.cfpie.com/showitem.aspx?productid=033&source=pharmacy
11th - 12th October 2010 in King of Prussia, PA, USA [2998]
How to Monitor Clinical Trials for GCP Compliance
Contact: Michael Roberts
Telephone: 610-688-1708
Email: info@cfpie.com
Website: http://www.cfpie.com/showitem.aspx?productid=043&s
11th - 13th October 2010 at the Lisboa Congress Center in Lisboa, Portugal [2667]
4th Annual Clinical Forum 2010
Dear Friends and Colleagues,
We have great pleasure in inviting you to participate in the DIA 4th Annual Clinical Forum 'Navigating the Future' from October 11-13 2010, in Lisbon, Portugal.
Contact: DIA Europe
Telephone: 41 61 225 51 51
Email: DIAEUROPE@DIAEUROPE.ORG
Website: http://www.diahome.org/DIAHOME/Education/FindEducationalOffering.aspx?productID=22350&eventType=Meeting
11th - 13th October 2010 at the Lowell Center in Madison, WI, USA [2985]
CMC Project Team Management: Principles and Practices for Successful Technical Leadership
Successful leadership of NCE/NBE and line extension development teams requires more than generating technical knowledge that is summarized in regulatory filings. This course, accordingly, addresses leadership essentials, team dynamics, meeting mechanics, and decision making styles and mechanisms, all in the context of CMC development.
Contact: Eric Buxton
Telephone: 608-265-2259; Fax: 608-262-2431
Email: ebuxton@pharmacy.wisc.edu
Website: http://ce.pharmacy.wisc.edu/courseinfo/2010TechnicalLeadership/
12th - 13th October 2010 in King of Prussia, PA, USA [3000]
Marketing, Advertising and Promotion of Pharmaceuticals and Medical Devices
Contact: Michael Roberts
Telephone: 610-688-1708
Email: info@cfpie.com
Website: http://www.cfpie.com/showitem.aspx?productid=056&source=pharmacy
13th - 14th October 2010 at the Marriott Bethesda Pooks Hill in Bethesda, MD, USA [2863]
Early Drug Development: Navigating the Treacherous Rapids
This dynamic, interactive, small molecule-focused workshop will teach you strategies to address the key issues facing project teams in the early drug development continuum. This workshop will incorporate a hands-on, small team, discussionbased approach with targeted presentations about real-world strategies that can be immediately applied to your development programs.
Event Code:
10023
Contact: Carrie Dunn
Telephone: 215.442.6181
Email: Carrie.Dunn@diahome.org
Website: http://www.diahome.org/DIAHOME/Education/FindEducationalOffering.aspx?productID=23646&eventType=Meeting
13th - 14th October 2010 at the Gaylord National Hotel & Convention Center in National Harbor, MD, USA [2802]
Making the Right Investments in Biomedical Informatics for Drug Development and Healthcare
How Health Care Data can be Used to Expand the Evidence Base and Promote Cost-eff ective Health Outcomes
Event Code:
10030
Contact: Rachel Minnick
Telephone: 215.442.6131
Email: Rachel.Minnick@diahome.org
Website: http://www.diahome.org/DIAHOME/Education/FindEducationalOffering.aspx?productID=23256&eventType=Meeting
13th - 14th October 2010 in King of Prussia, PA, USA [3001]
Detecting Fraud & Misconduct in Clinical Trials
Contact: Michael Roberts
Telephone: 610-688-1708
Email: info@cfpie.com
Website: http://www.cfpie.com/showitem.aspx?productid=117&source=pharmacy
13th - 15th October 2010 in King of Prussia, PA, USA [3002]
Process Validation for Medical Devices
Contact: Michael Roberts
Telephone: 610-688-1708
Email: info@cfpie.com
Website: http://www.cfpie.com/showitem.aspx?productid=089&source=pharmacy
13th - 15th October 2010 in King of Prussia, PA, USA [3003]
QA/QC Strategy for Biopharmaceuticals and Biologics
Contact: Michael Roberts
Telephone: 610-688-1708
Email: info@cfpie.com
Website: http://www.cfpie.com/showitem.aspx?productid=065&source=pharmacy
13th - 14th October 2010 at the Gaylord National Resort & Convention Center in National Harbor, MD , USA [2888]
Investing in Biomedical Informatics for Drug Development and Health Care
How Health Care Data can be Used to Expand the Evidence Base and Promote Cost-eff ective Health Outcomes
Event Code:
10030
Contact: Rachel Minnick
Telephone: 215.442.6131
Email: Rachel.Minnick@diahome.org
Website: http://www.diahome.org/DIAHome/Education/FindEducationalOffering.aspx?productID=23256&eventType=Meeting
13th - 14th October 2010 at the DoubleTree Hotel and Executive Meeting Center in Bethesda, MD, USA [3053]
Maternal and Pediatric Drug Safety Symposium
Maternal and pediatric drug safety is becoming increasingly important areas in the life cycle of medical compounds. Recent regulatory guidelines and scientific findings have emphasized the need to collect, analyze, and report data of the highest quality to healthcare providers and patients
Event Code:
10032
Contact: Constance Burnett
Telephone: 215.293.5800
Email: constance.burnett@diahome.org
Website: http://www.diahome.org/DIAHome/Education/FindEducationalOffering.aspx?productID=23874&eventType=Meeting
14th - 15th October 2010 at the Hilton Rockville Hotel in Rockville, MD , USA [2961]
DIA and FDA Office of Women’s Health (OWH) Present: Partnerships to Advance Patient Recruitment and Retention in Clinical Research
DIA and FDA Office of Women’s Health (OWH) Host First Patient Recruitment and Retention Conference.
Contact: Constance Burnett
Telephone: 215.293.5800
Email: Constance.Burnett@diahome.org
Website: http://www.diahome.org/DIAHome/Education/FindEducationalOffering.aspx?productID=22727&eventType=Meeting
14th - 15th October 2010 in King of Prussia, PA, USA [3004]
Pharmaceutical Production Batch Record Review
Contact: Michael Roberts
Telephone: 610-688-1708
Email: info@cfpie.com
Website: http://www.cfpie.com/showitem.aspx?productid=058&source=pharmacy
14th - 15th October 2010 in Boulogne-Billancourt (Paris) , France [2850]
Crisis Management
Crisis prevention is extremely important in the drug development community and proper
management of a crisis is crucial for the reliability of the company or regulator.
Event Code:
10564
Contact: DIA Europe
Telephone: 41 61 225 51 51
Email: DIAEUROPE@DIAEUROPE.ORG
Website: http://www.diahome.org/DIAHOME/Education/FindEducationalOffering.aspx?productID=23214&eventType=Training%20Course
18th - 19th October 2010 in King of Prussia, PA, USA [3005]
Analytical Method Validation for Biologics, Biopharmaceuticals and Other Therapeutic Products
Contact: Michael Roberts
Telephone: 610-688-1708
Email: info@cfpie.com
Website: http://www.cfpie.com/showitem.aspx?productid=096&source=pharmacy
18th - 20th October 2010 in King of Prussia, PA, USA [3006]
Biostatistics for Non-Statisticians
Contact: Michael Roberts
Telephone: 610-688-1708
Email: info@cfpie.com
Website: http://www.cfpie.com/showitem.aspx?productid=010&source=pharmacy
18th - 21st October 2010 in Shanghai, China [2874]
BioManufaturing World
BioManufacturing World is the largest global conference in China that will gather leading international and Chinese biopharmaceutical manufacturers, CMOs, regional development agencies, technocrats and solution providers to share new ideas, discuss best business strategies, most advanced technical practices and latest partnership models that will improve efficiency, product quality and profitability
Contact: Evelyn Toh
Telephone: 65 6618 1756; Fax: 65 6826 4316
Email: evelyn.toh@imapac.com
Website: http://www.biomanufacturingworld.com
18th - 21st October 2010 at the Radisson BLU Alcron Hotel in Prague, Czech Republic [2851]
US Regulatory Affairs
This course will focus on drug and biologic products; the regulatory process for devices or multi-sourced (generic) products will not be addressed.
Event Code:
10552
Contact: DIA Europe
Telephone: 41 61 225 51 51
Email: DIAEUROPE@DIAEUROPE.ORG
Website: http://www.diahome.org/DIAHOME/Education/FindEducationalOffering.aspx?productID=22598&eventType=Training%20Course
18th - 20th October 2010 at the Drug Information Association, Inc. in Horsham, PA, USA [2852]
Essentials of Project Management
Take advantage of presentations and hands-on interactive practice of project management tools, techniques, and methods in a biotech/pharmaceutical industry setting.
Event Code:
10427
Contact: Laura Parker
Telephone: 215-442-6101
Email: Laura.Parker@diahome.org
Website: http://www.diahome.org/DIAHOME/Education/FindEducationalOffering.aspx?productID=21427&eventType=Training%20Course
18th - 21st October 2010 in Shanghai, China [2980]
Vaccine Manufacturing World
The ONLY vaccine manufacturing meeting in China and Asia Pacific region bringing together international and Chinese vaccine manufacturers, regulators CMOs, regional development agencies, platform technology and other service providers to share new ideas, discuss best manufacturing strategies, most advanced technical practices and latest partnership models that will improve efficiency, product quality and profitability, at a time of regulatory change and market boom in China.
Contact: Evelyn Toh
Telephone: +65 66181756; Fax: +65 68264316
Email: evelyn.toh@imapac.com
Website: http://www.biomanufacturingworld.com
18th - 20th October 2010 at the Monitor website in Beijing, China [3079]
Joint DIA-ACT Study Director Workshop
Although this workshop is directed towards early-career toxicologists and related professional in the CRO industry, this course would be valuable to a broad range of nonclinical, clinical, management and regulatory personnel in pharmaceutical, medical device, biotechnology, commodity chemical and other industrial sector companies. Event Code:
10980
Contact: Stephanie Liu
Telephone: 86 10 5923 1109
Email: dia@diachina.org
Website: http://www.diahome.org/DIAHome/Education/FindEducationalOffering.aspx?productID=23939&eventType=Meeting
19th - 20th October 2010 at the Drug Information Association, Inc. in Horsham, PA, USA [2853]
New Drug Product Development & Lifecycle Management
Develop New Drugs While Expanding the Lifecycle of Inline Products
Event Code:
10432
Contact: Laura Parker
Telephone: 215-442-6101
Email: Laura.Parker@diahome.org
Website: http://www.diahome.org/DIAHOME/Education/FindEducationalOffering.aspx?productID=21432&eventType=Training%20Course
20th October 2010 at the Imperia Conference Center in Somerset, NJ, USA [2971]
Validation, Verification and Transfer of Analytical Methods
An interactive University of Wisconsin School of Pharmacy short course.
Contact: James E. De Muth, Ph.D.
Telephone: 608-262-2422; Fax: 608-262-2431
Email: jedemuth@pharmacy.wisc.edu
Website: http://ce.pharmacy.wisc.edu/course/category.php?id=18
20th October 2010 at the Imperia Conference Center in Somerset, NJ, USA [2972]
Solubilization and Enhanced Oral Bioavailability Formulations
This University of Wisconsin School of Pharmacy short course covers background and practical aspects of solubilization and enhanced oral bioavailability formulation strategies.
Contact: James E. De Muth, Ph.D.
Telephone: 608-262-2422; Fax: 608-262-2431
Email: jedemuth@pharmacy.wisc.edu
Website: http://ce.pharmacy.wisc.edu/course/category.php?id=18
20th October 2010 at the Online Event in Palo Alto,CA, USA [3111]
Gamma Sterilizer Validation: Method 1 and VDmax25 per ISO 11137
This Sterilization validation training will review the general requirements for validation as described in ISO 11137:2006.
Contact: admin
Telephone: +1-650-620-3915; Fax: +1-650-963-2556
Email: admin@complianceonline.com
Website: http://www.complianceonline.com/ecommerce/control/trainingFocus/~product_id=701255?channel=pharmorg
20th October 2010 at the Imperia Conference Center in Somerset, NJ, USA [2973]
Multifactor Design of Experiments in Pharmaceutical Development, Manufacturing, and Quality Control
This University of Wisconsin School of Pharmacy short course will introduce the attendee to the tools and software useful for planning and analyzing their experiments. Examples will be utilized to illustrate the implementation of DOE, as well as its successful use in various areas of pharmaceutical development, manufacturing, and quality control.
Contact: James E. De Muth, Ph.D.
Telephone: 608-262-2422; Fax: 608-262-2431
Email: jedemuth@pharmacy.wisc.edu
Website: http://ce.pharmacy.wisc.edu/course/category.php?id=18
20th October 2010 at the Imperia Conference Center in Somerset, NJ, USA [2974]
Characterization and Impact of Water-Solid Interactions in Pharmaceutical Systems
The purpose of this University of Wisconsin School of Pharmacy short course is to provide the participant with a basic understanding of the principles that govern the interaction of residual water with pharmaceutical solids, and the effects of such water on the physical and chemical properties of solids.
Contact: James E. De Muth, Ph.D.
Telephone: 608-262-2422; Fax: 608-262-2431
Email: jedemuth@pharmacy.wisc.edu
Website: http://ce.pharmacy.wisc.edu/course/category.php?id=18
20th - 22nd October 2010 in King of Prussia, PA, USA [3007]
CMC Regulatory Compliance for Biopharmaceuticals and Biologics
Contact: Michael Roberts
Telephone: 610-688-1708
Email: info@cfpie.com
Website: http://www.cfpie.com/showitem.aspx?productid=017&source=pharmacy
21st October 2010 at the Imperia Conference Center in Somerset, NJ, USA [2975]
QbD for Solid Dosage Forms: Designing Tablet Formulations Based on API Physical Properties
The objective of this University of Wisconsin School of Pharmacy short course is to provide the participant with an understanding of how fundamental physical properties of APIs impact the design and manufacture of tablet dosage forms.
Contact: James E. De Muth, Ph.D.
Telephone: 608-262-2422; Fax: 608-262-2431
Email: jedemuth@pharmacy.wisc.edu
Website: http://ce.pharmacy.wisc.edu/course/category.php?id=18
21st - 22nd October 2010 at the Drug Information Association, Inc. in Horsham, PA, USA [2854]
Enterprise Resource Planning
Event Code:
10415
Contact: Laura Parker
Telephone: 215-442-6101
Email: Laura.Parker@diahome.org
Website: http://www.diahome.org/DIAHOME/Education/FindEducationalOffering.aspx?productID=21403&eventType=Training%20Course
21st - 22nd October 2010 at the Drug Information Association, Inc in Horsham, PA, USA [2855]
Executing and Controlling Projects
Create Project Plans that Exceed Your Business Goals
Contact: Laura Parker
Telephone: 215-442-6101
Email: Laura.Parker@diahome.org
Website: http://www.diahome.org/DIAHOME/Education/FindEducationalOffering.aspx?productID=21389&eventType=Training%20Course
21st October 2010 at the Imperia Conference Center in Somerset, NJ, USA [2976]
Developing and Troubleshooting Dissolution Methods
This interactive University of Wisconsin School of Pharmacy short course is designed to provide practical tools for those developing dissolution methods at various stages (including biorelevant methods), and to provide an understanding of the development process for managers, formulators and regulatory affairs/CMC personnel Building on the history of dissolution, learner is presented with a systematic approach to develop dissolution methods.
Contact: James E. De Muth, Ph.D.
Telephone: 608-262-2422; Fax: 608-262-2431
Email: jedemuth@pharmacy.wisc.edu
Website: http://ce.pharmacy.wisc.edu/course/category.php?id=18
21st October 2010 at the Imperia Conference Center in Somerset, NJ, USA [2977]
Statistical Considerations in Analytical Method Validation
This University of Wisconsin School of Pharmacy short course will cover statistical considerations in method validation, which help demonstrate that the method is fit for use, while protecting the laboratory from earmarking a suitable method as invalid.
Contact: James E. De Muth, Ph.D.
Telephone: 608-262-2422; Fax: 608-262-2431
Email: jedemuth@pharmacy.wisc.edu
Website: http://ce.pharmacy.wisc.edu/course/category.php?id=18
21st October 2010 at the Imperia Conference Center in Somerset, NJ, USA [2978]
Practical Applications of Instrumentation in QbD/PAT
This University of Wisconsin School of Pharmacy short course describes the numerous tools used to develop PAT and QbD programs. It will clearly show the differences between current methodology and what is needed to perform a successful PAT and/or QbD program. It cover available technologies, how they work, what they do, and what may be done with the data generated. It will introduce the concepts of continuous monitoring of Critical to Quality parameters and how they may be applied.
Contact: James E. De Muth, Ph.D.
Telephone: 608-262-2422; Fax: 608-262-2431
Email: jedemuth@pharmacy.wisc.edu
Website: http://ce.pharmacy.wisc.edu/course/category.php?id=18
21st - 22nd October 2010 in King of Prussia, PA, USA [3008]
Introduction to Statistical Analysis of Laboratory Data
Contact: Michael Roberts
Telephone: 610-688-1708
Email: info@cfpie.com
Website: http://www.cfpie.com/showitem.aspx?productid=046&source=pharmacy
21st - 22nd October 2010 in Berlin, Germany [3009]
Auditing and Qualifying Suppliers and Vendors
Contact: Michael Roberts
Telephone: 610-688-1708
Email: info@cfpie.com
Website: http://www.cfpie.com/showitem.aspx?productid=004&source=pharmacy
21st - 22nd October 2010 in King of Prussia, PA, USA [3010]
Essentials of Program, Project & Portfolio Management in Bio/Pharmaceutical Discovery
Contact: Michael Roberts
Telephone: 610-688-1708
Email: info@cfpie.com
Website: http://www.cfpie.com/showitem.aspx?productid=123&source=pharmacy
23rd - 26th October 2010 at the Beijing International Convention Center in beijing, China [2605]
BIT's 8th Annual World Congress of International Drug Discovery Science and Technology (IDDST)
The IDDST congress is initiated by BIT Life Sciences in 2003, with 7 years¡¯ contribution in the field of drug discovery and development, it has became a leading international event for the professionals to pinpoint and identify opportunities and market needs, explore Asian demand and get updated on latest breakthroughs in drug R&D.
Contact: Amy Zhou
Telephone: 0086-411-84799609-801; Fax: 0086-411-84799629
Email: amy@iddst.com
Website: http://www.iddst.com/iddst2010/
23rd - 26th October 2010 at the Hotel the Lalit Ashok in Bangalore, India [3054]
5th Annual Conference on Drug Discovery and Clinical Development Meeting the Challenges of Next Generation R&D: Enhancing Efficiency, Effectiveness and Innovation
Conference Topics:
* Drug Discovery
* Regulatory Aff airs
* Early / Pre-Clinical Development
* Clinical Operations
* Quality Assurance and Compliance
* Biologics and Vaccines
* Pharmacovigilance and Drug Safety
* Clinical Data Management, Biostatistics, and Medical Writing
* Central Lab Management
* Clinical Trial Logistics / Supplies Management
Event Code:
10659
Contact: Fahd.Khan
Telephone: 91-9223267327
Email: Fahd.Khan@diaindia.org
Website: http://www.diahome.org/DIAHome/Education/FindEducationalOffering.aspx?productID=23796&eventType=Meeting
25th - 26th October 2010 in Nice, France [2862]
4th European Cardiac Safety Conference
Cardiovascular safety of new drugs has been at the center of public attention and concern for more than a decade.
Event Code:
10113
Contact: DIA Europe
Telephone: 41612255151
Email: DIAEUROPE@DIAEUROPE.ORG
Website: http://www.diahome.org/DIAHOME/Education/FindEducationalOffering.aspx?productID=23320&eventType=Meeting
25th - 26th October 2010 at the The westing arlington gateway in arlington, VA [2965]
2nd Annual medicare advantage strategic business symposium
Opal Events is pleased to bring together the best and brightest of the Medicare Advantage community for our 2nd annual Medicare business forum. We will discuss not only the problems but also the solutions facing the managed care industry in this 2-day, multi-tracked, Medicare Advantage conference.
Contact: Pete jackson
Email: marketing@opalevents.org
Website: http://www.opalevents.org/conferencehtml/2010/medicare_advantage_strategic_business_symposium_2010/medicare_advantage_strategic_business_symposium.php
25th - 29th October 2010 at the Hotel Renaissance Penta in Vienna, Austria [2856]
Excellence in Pharmacovigilance: Clinical Trials and Post Marketing
This course is designed to provide a firm grounding in key aspects of Global Clinical Pre and Post Marketing Safety. This five-day training course, presented by the European Medicines Agency, is the only one of its kind.
Contact: DIA Europe
Telephone: 41 61 225 51 51
Email: DIAEUROPE@DIAEUROPE.ORG
Website: http://www.diahome.org/DIAHOME/Education/FindEducationalOffering.aspx?productID=21817&eventType=Training%20Course
25th - 26th October 2010 at the Singapore in Singapore, Singapore [2960]
5th Annual Generics Asia Summit
The 5th Annual Generics Asia Summit will bring together C-level decision makers from Generics companies,innovator pharma companies, payers, investors,regulators and health authorities.
This is the only event in Asia to have truly substantial & relevant discussions on hot issues such as leveraging on brands, biosimilars, regulatory updates and collaboration opportunities between innovator pharma and traditional generics companies.
Contact: Rita Parasurum
Telephone: 6565082482
Email: rita.parasurum@ibcasia.com.sg
Website: http://www.generics-asia.com/
25th - 26th October 2010 in Berlin, Germany [3011]
Best Practices for an Effective Cleaning Validation Program
Contact: Michael Roberts
Telephone: 610-688-1708
Email: info@cfpie.com
Website: http://www.cfpie.com/showitem.aspx?productid=007&source=pharmacy
25th - 26th October 2010 in King of Prussia, PA, USA [3012]
Design Control for Medical Device Professionals
Contact: Michael Roberts
Telephone: 610-688-1708
Email: info@cfpie.com
Website: http://www.cfpie.com/showitem.aspx?productid=024&source=pharmacy
25th - 26th October 2010 in King of Prussia, PA, USA [3013]
Effective Document Management for the Pharmaceutical, Biotech & Medical Device Industries
Contact: Michael Roberts
Telephone: 610-688-1708
Email: info@cfpie.com
Website: http://www.cfpie.com/showitem.aspx?productid=027&source=pharmacy
26th - 29th October 2010 in Singapore, Singapore [2799]
World Stem Cells and Regenerative Medicines Congress Asia 2010
World Stem Cells and Regenerative Medicines Congress Asia will bring together global and regional pharma, biotechs, investors and academic scientific leaders who are in the stem cell and regenerative medicines field to uncover Asia’s market potential, scientific capability and opportunities for collaborations in fast-tracking research development and commercialization of stem cell therapies and applications in the global marketplace.
Contact: Esther Chan
Telephone: +65 6322 2742
Email: esther.chan@terrapinn.com
Website: http://www.terrapinn.com/2010/stemcellsasia/
26th - 27th October 2010 at the Novotel Singapore Clarke Quay in Singapore, Singapore [3086]
Pharmacovigilance Asia 2010
Pharmacovigilance Asia 2010 – Asia’s 1st ever regional conference focusing on pharmacovigilance and drug safety!
Contact: Mr Manager
Telephone: 65 67229388
Email: enquiry@iqpc.com.sg
Website: http://pharmacovigilanceasia.com/Event.aspx?id=335820
26th - 27th October 2010 in Bethesda, MD, USA [2843]
Ensuring Quality And Balancing Risks For Multiregional Clinical Trials: Statistical, Clinical, Regulatory, And Ethical Factors
Join Industry and Regulatory Leaders to Address Multi regional Clinical Trial Opportunities and Risks from a Global Perspective
Event Code:
10034
Contact: Constance Burnett
Telephone: 215.293.5800
Email: Constance.Burnett@diahome.org
Website: http://www.diahome.org/DIAHOME/Education/FindEducationalOffering.aspx?productID=23615&eventType=Meeting
26th - 27th October 2010 in King of Prussia, PA, USA [3014]
Pediatric Clinical Trial Design - Ethics, Management and Regulatory Requirements
Contact: Michael Roberts
Telephone: 610-688-1708
Email: info@cfpie.com
Website: http://www.cfpie.com/showitem.aspx?productid=115&source=pharmacy
26th - 27th October 2010 at the DoubleTree Hotel and Executive Meeting Center in Bethesda, MD , USA [3055]
Tomorrow\'s Project Manager: Evolving Competencies for Biopharmaceutical Professionals
Address leading issues for the project management community, engage in discussions with leading project management experts, and discover competency model elements suitable for best practices.
Event Code:
10028
Contact: Constance Burnett
Telephone: .215.293.5800
Email: Constance.Burnett@diahome.org
Website: http://www.diahome.org/DIAHome/Education/FindEducationalOffering.aspx?productID=23877&eventType=Meeting
27th - 28th October 2010 at the The westing arlington gateway in arlington, VA [2966]
Medicaid Business in focus: CFO Forum
Our conference provides solutions in these areas and more all tailored specifically for the chief financial officer! Join us for this unique event.
This business conference is designed for executives from Medicaid health plans, specifically the CFO-level and others with finance & medical management responsibilities.
Contact: Pete jackson
Email: marketing@opalevents.org
Website: http://www.opalevents.org/conferencehtml/2010/medicaid_in_focus_2010/medicaid_in_focus.php
27th - 29th October 2010 at the Novotel in Geneva, Switzerland [2857]
Good Management of Medical Devices
Day I will deliver the knowledge base for the subsequent days.
Day II
The course will give a clear guide how to develop practically a medical device.
Day III
Responsibility in post marketing surveillance of medical devices (and drug devices combination products) according to the Medical Device Vigilance System will be explained and illustrated by examples.
Emphasis that 2007 47 comes into force in 2010
Event Code:
10547
Contact: DIA Europe
Telephone: 41 61 225 51 51
Email: DIAEUROPE@DIAEUROPE.ORG
Website: http://www.diahome.org/DIAHOME/Education/FindEducationalOffering.aspx?productID=22390&eventType=Training%20Course
27th - 28th October 2010 in King of Prussia, PA, USA [3015]
Design Validation, Verification, and Risk Analysis for Medical Device Professionals
Contact: Michael Roberts
Telephone: 610-688-1708
Email: info@cfpie.com
Website: http://www.cfpie.com/showitem.aspx?productid=118&source=pharmacy
27th - 28th October 2010 in Berlin, Germany [3016]
Process Validation for Drugs and Biologics
Contact: Michael Roberts
Telephone: 610-688-1708
Email: info@cfpie.com
Website: http://www.cfpie.com/showitem.aspx?productid=049&source=pharmacy
28th - 29th October 2010 at the Tower Hall Funabori in Tokyo, Japan [2788]
7th DIA Japan Annual Meeting
See website for conference overview
Contact: DIA Japan
Telephone: 81-3-5833-8444
Email: diajapan@diajapanj.org
Website: http://www.diahome.org/DIAHOME/Education/FindEducationalOffering.aspx?productID=23312&eventType=Meeting
28th - 29th October 2010 at the Omni parker house in boston, MA [2967]
2nd annual drug discovery partnerships: filling the pipeline
This drug discovery conference brings together pharmaceutical companies, small biotechnology enterprises, government agencies, for-profit and not-for profit research institutions to exchange ideas, make connections and discuss opportunities to create an environment that will foster pharmaceutical innovation.
Contact: Pete jackson
Email: marketing@opalevents.org
Website: http://www.opalevents.org/conferencehtml/2010/drug_discovery_partnership_2010/drug_discovery_partnership.php
28th - 29th October 2010 at the Novotel in Geneva, Switzerland [2858]
An Introduction to Product Information Management (PIM)
This training course is designed to give the participants a good understanding about Product Information Management, the PIM submission process and variations, the translation process and comment handling as well as the exchange standard and templates used.
Event Code:
10539
Contact: DIA Europe
Telephone: 41 61 225 51 51
Email: DIAEUROPE@DIAEUROPE.ORG
Website: http://www.diahome.org/DIAHOME/Education/FindEducationalOffering.aspx?productID=21816&eventType=Training%20Course
28th - 29th October 2010 in King of Prussia, PA, USA [3017]
FDA Inspections of Clinical Data Systems
Contact: Michael Roberts
Telephone: 610-688-1708
Email: info@cfpie.com
Website: http://www.cfpie.com/showitem.aspx?productid=034&source=pharmacy
28th - 29th October 2010 in King of Prussia, PA, USA [3018]
Introduction to Effective Medical Writing
Contact: Michael Roberts
Telephone: 610-688-1708
Email: info@cfpie.com
Website: http://www.cfpie.com/showitem.aspx?productid=047&source=pharmacy
29th October 2010 at the PSGIMS and R in COIMBATORE, TAMILNADU, INDIA [3100]
Emerging Opportunities and Challenges For Clinical Pharmacist In National Health Care
National level symposium on clinical pharmacy is a national event focusing on the current challenges of clinical pharmacist in patient care
Contact: ANDHUVAN.G
Telephone: 0422-435841; Fax: 2594400
Email: visitandhuvan@yahoo.com
1st - 2nd November 2010 at the The Peterhouse, University of Cambridge in Cambridge, UK [2959]
MicroRNAs Europe 2010 Meeting on MicroRNAs: Biology to Development & Disease
MicroRNAs Discovery and Biogenesis
MicroRNAs in Development
Bioinformatics of miRNAs
MicroRNAs in Virology & Diagnostics
MicroRNAs in Stem Cell Biology
MicroRNAs in Disease Biology
Contact: Dr Krishnarao Appasani
Telephone: 781-891-8181; Fax: 781-891-8234
Email: Genexpsys@expressgenes.com
Website: http://www.expressgenes.com/
1st - 2nd November 2010 at the La Concha reinaissance San juan Resort in san juan, Puerto Rico [2968]
Medicare advantage strategic business symposium: Puerto Rico
Opal Events is pleased to announce we are bringing a major Medicare Advantage conference to Puerto Rico to discuss MA topics that pertain specifically to PR payers and providers! This is the conference to attend to find out exactly how federal health reform issues will affect Medicare Advantage on the island.
Contact: pete jackson
Email: marketing@opalevents.org
Website: http://www.opalevents.org/conferencehtml/2010/medicare_advantage_strategic_business_symposium_pr_2010/medicare_advantage_strategic_business_symposium_pr.php
1st - 2nd November 2010 at the The Peterhouse, University of Cambridge in Cambridge, United Kingdom [2983]
Fifth International ‘MicroRNAs Europe 2010’ Meeting on ‘MicroRNAs: Biology to Development & Disease’
“A Unique Theme to Combine Developmental Biology with Disease Biology”
Key words: microRNAs, microRNA biogenesis, small non coding RNAs, piRNAs, RNAi micrornas in stem cells, micrornas in vascular diseases, micrornas in cancer, microRNA libraries, microRNAs in immunity, microRNAs in diabètes, microRNAs in ageing.
Contact: Dr Krishnarao Appasani
Telephone: 781-891-8181; Fax: 781-891-8234
Email: Genexpsys@expressgenes.com
Website: http://www.expressgenes.com
1st - 2nd November 2010 in King of Prussia, PA, USA [3019]
Project Management for Phase 1 & 2 Clinical Trials
Contact: Michael Roberts
Telephone: 610-688-1708
Email: info@cfpie.com
Website: http://www.cfpie.com/showitem.aspx?productid=100&source=pharmacy
2nd - 3rd November 2010 at the Holiday Inn Somerset in Somerset , USA [2883]
Cold Chain & Logistics Management
Preliminary Outline
An Important Two-Day Conference with Interactive Exercise and Case Studies on:
Regulatory changes and guidance expected in 2010
New Regulations on Storage, Handling and Distribution of Drug Samples & Mail-Order Drugs
Extrapolating Future Regulatory Requirements In-line with Cold Chain Trends
Harmonized Guidance for the Storage and Transport of Temperature Sensitive Therapeutic Products
Contact: Rebecca Tan
Telephone: 416.410.7402; Fax: 905.472.1819
Email: enquiry@ipacanada.com
Website: http://www.ipacanada.com/viewcourse.php?id=coldchain1110nj
2nd - 3rd November 2010 at the Holiday Inn Somerset in Somerset, NJ, Canada [2956]
Cold Chain & Logistics Management
Preliminary Outline
An Important Two-Day Conference with Interactive Exercise and Case Studies on:
Regulatory changes and guidance expected in 2010
New Regulations on Storage, Handling and Distribution of Drug Samples & Mail-Order Drugs
Extrapolating Future Regulatory Requirements In-line with Cold Chain Trends
Contact: Rebecca Tan
Telephone: 416.410.7402; Fax: 905.472.1819
Email: enquiry@ipacanada.com
Website: http://www.ipacanada.com/viewcourse.php?id=coldchain1110nj
2nd - 3rd November 2010 in Berlin, Germany [3020]
Preparation of FDA Submissions (INDs, NDAs, BLAs, ANDAs, Post-Approval Supplements) and Communicating with the FDA
Contact: Michael Roberts
Telephone: 610-688-1708
Email: info@cfpie.com
Website: http://www.cfpie.com/showitem.aspx?productid=085&source=pharmacy
2nd - 3rd November 2010 in Berlin, Germany [3021]
Selecting and Managing CRO\'s
Contact: Michael Roberts
Telephone: 610-688-1708
Email: info@cfpie.com
Website: http://www.cfpie.com/showitem.aspx?productid=086&source=pharmacy
3rd November 2010 at the Radisson Blu Hotel Paris Charles De Gaulle Airport in Le Mesnil Amelot, Paris , France [2873]
Future Direction for Orphan Drugs in Europe
This conference will reflect on the experience gained in the first ten years of the European Orphan Medicinal Products regulation and provide an outlook on future developments. Learning and outcomes from the European Medicines Agency ten year celebration conference on Orphan Medicinal Products will also be shared.
Contact: DIA Europe
Telephone: 41 61 225 51 51
Email: DIAEUROPE@DIAEUROPE.ORG
Website: http://www.diahome.org/DIAHOME/Education/FindEducationalOffering.aspx?productID=23718&eventType=Meeting
3rd - 5th November 2010 at the Westin Ottawa Hotel in Ottawa, Canada [2829]
DIA’s 8th Annual Canadian Meeting: “Keeping Canada on the Map: Fostering Innovation and Access to Drugs in Canada”
CALL FOR ABSTRACTS
for Presentations (details on page 3)
for Posters (details on page 2)
All abstracts are due by October 18, 2010
PROGRAM OVERVIEW
The biopharmaceutical community is experiencing a paradigm shift in drug development. Important global changes are occurring with respect to regulatory oversight to clinical trial design and execution.
Contact: Joanne Wallace
Telephone: .215.442.6180
Email: Joanne.Wallace@diahome.org
Website: http://www.diahome.org/DIAHOME/Education/FindEducationalOffering.aspx?productID=23405&eventType=Meeting
3rd - 5th November 2010 in King of Prussia, PA, USA [3022]
Optimization of Drug-Like Properties in Drug Discovery – Assessment and Structure Modification Strategies
Contact: Michael Roberts
Telephone: 610-688-1708
Email: info@cfpie.com
Website: http://www.cfpie.com/showitem.aspx?productid=022&source=pharmacy
3rd - 4th November 2010 in King of Prussia, USA [3023]
Project Management for the Phase 3 and LCM (Life Cycle Management) of the Drug Development Process
Contact: Michael Roberts
Telephone: 610-688-1708
Email: info@cfpie.com
Website: http://www.cfpie.com/showitem.aspx?productid=101&source=pharmacy
3rd - 5th November 2010 in King of Prussia, PA, USA [3024]
Spectroscopic Method Development for the Pharmaceutical and Biotech Industries
Contact: Michael Roberts
Telephone: 610-688-1708
Email: info@cfpie.com
Website: http://www.cfpie.com/showitem.aspx?productid=125&source=pharmacy
4th - 5th November 2010 at the University of Technology in Graz,, Austria [2885]
Quality by Design: A Hands-on Short Course for Pharma
In this short course the key elements of Quality by Design, i.e. Quality Risk Management (QRM), Process Characterisation, Design of Experiments (DoE), Development of a Design Space and Control Strategy, as well as the tools of Knowledge Management will be introduced.
This course is a hands on course full of practical work. It is necessary that you bring your laptop with you.
Event Code:
10565
Contact: DIA Europe
Telephone: 41 61 225 51 51
Email: DIAEUROPE@DIAEUROPE.ORG
Website: http://www.diahome.org/DIAHome/Education/FindEducationalOffering.aspx?productID=23682&eventType=Training Course
4th - 5th November 2010 at the Radisson Blu Hotel Paris Charles De Gaulle Airport in Le Mesnil Amelot, Paris , France [2872]
Second Health Technology Assessment (HTA) Conference
This workshop will bring together all stakeholders – from regulators to governments, from national competent authorities to the European Medicines Agency in London and from industry, payers and – the ultimate beneficiary of a successfully functioning system – the patients who stand to benefit from the fruits of innovative R&D.
Contact: DIA Europe
Telephone: 41 61 225 51 51
Email: DIAEUROPE@DIAEUROPE.ORG
Website: http://www.diahome.org/DIAHOME/Education/FindEducationalOffering.aspx?productID=23719&eventType=Meeting
4th - 5th November 2010 at the The National Labor Conference Center in Lansdowne, VA , USA [2958]
DIA/FDA Orphan Drug Designation Workshop
WORKSHOP HIGHLIGHTS
* Application Writing
* One-on-One Guidance and Counseling with FDA – Sponsors will have one 45-minute and one 30-minute consultative session with an FDA OOPD staff member and two 20-minute follow-up sessions with an FDA OOPD staff member
* Final applications will be submitted to the FDA onsite at the close of the workshop or within 30 days.
Event Code:
10037
Contact: Constance Burnett Program Developer
Telephone: 215.293-5800
Email: Constance.Burnett@diahome.org
Website: http://www.diahome.org/DIAHome/Education/FindEducationalOffering.aspx?productID=23774&eventType=Meeting
4th - 5th November 2010 in Berlin, Germany [3025]
Drug Master Files (DMFs) - Understanding and Meeting Your Regulatory and Processing Responsibilities
Contact: Michael Roberts
Telephone: 610-688-1708
Email: info@cfpie.com
Website: http://www.cfpie.com/showitem.aspx?productid=026&source=pharmacy
4th - 5th November 2010 in King of Prussia, PA, USA [3026]
Effective Laboratory Safety Management
Contact: Michael Roberts
Telephone: 610-688-1708
Email: info@cfpie.com
Website: http://www.cfpie.com/showitem.aspx?productid=088&source=pharmacy
4th - 5th November 2010 in Berlin, Germany [3027]
Stability Programs for Product Shelf Life - From Development to Approval
Contact: Michael Roberts
Telephone: 610-688-1708
Email: info@cfpie.com
Website: http://www.cfpie.com/showitem.aspx?productid=072&source=pharmacy
4th - 5th November 2010 at the Crowne Plaza Sun Palace in Beijing, China [3077]
Understanding the Statistical Thinking in Clinical Research for Drug Development
Built on an overview of fundamental statistical concepts, this 2-day training workshop is designed as an in-depth, practical, basic- to intermediate-level introduction to selected clinical research designs and statistical methodologies, for drug research and development professionals who have regular exposure to statistics either through studies or professional experience.
Event Code:
10981
Contact: Stephanie Liu
Telephone: 86-10-59231109
Email: dia@diachina.org
Website: http://www.diahome.org/DIAHome/Education/FindEducationalOffering.aspx?productID=23941&eventType=Meeting
5th November 2010 at the Online Event in Palo Alto,CA, USA [3122]
Excel Spreadsheets - Develop and Validate to Eliminate 483s
Learn how to Use excel spreadsheet for GXP data and reduce validation cost and time. Configure Excel for audit trails, security features, and data entry verification.
Contact: admin
Telephone: +1-650-620-3915; Fax: +1-650-963-2556
Email: admin@complianceonline.com
Website: http://www.complianceonline.com/ecommerce/control/trainingFocus/~product_id=701688?channel=pharmorg
8th - 9th November 2010 in King of Prussia, PA, USA [3028]
Cleanroom Microbiology for the Non-Microbiologist
Contact: Michael Roberts
Telephone: 610-688-1708
Email: info@cfpie.com
Website: http://www.cfpie.com/showitem.aspx?productid=016&source=pharmacy
8th - 10th November 2010 at the DoubleTree Hotel and Executive Meeting Center in Bethesda, MD, USA [3056]
Sustaining Clinical Trial Disclosure: Going Green
Conference: November 9-10, 2010
Preconference Workshop: November 8, 2010
* What Are the Connections Between HL7 and Clinical Trial Disclosure?
(Preregistration required – monitor www.diahome.org for fee.)
Interact with Speakers from Industry and Regulatory and Government Agencies to Explore Global Perspectives on the Complexities of Clinical Trial Disclosure
Event Code:
10031
Contact: Carrie Dunn
Telephone: 215.442.6181
Email: Carrie.Dunn@diahome.org
Website: http://www.diahome.org/DIAHome/Education/FindEducationalOffering.aspx?productID=23783&eventType=Meeting
9th November 2010 at the Moevenpick Hotel Zuerich Airport in Glattbrug, , Switzerland [2864]
Combination Products - Finding the Right Regulatory Strategy
This one-day conference will provide delegates with an understanding of the regulatory framework and highlight the
challenges developing combination products. It will focus on the differences between device and pharma regulations and will provide examples of issues faced by manufacturers already operating on the medicinal product/medical device borderline, designing products where the regulatory framework is not immediately obvious.
Contact: DIA Europe
Telephone: 41 61 225 51 51
Email: DIAEUROPE@DIAEUROPE.ORG
Website: http://www.diahome.org/DIAHOME/Education/FindEducationalOffering.aspx?productID=23319&eventType=Meeting
10th - 12th November 2010 at the Maksoud Plaza Sao Paulo Hotel/Convention Center in São Paulo,, Brazil [2877]
7th Latin American Congress of Clinical Research Harmonization and the Future of Drug Development in Latin America
This three-day congress will include two pre-congress courses and a two-day conference focusing on both the global and regional aspects of clinical research.
Event Code:
10902
Registrations being handled by a 3rd party
Contact: Managing Eventos
Telephone: (55 11) 5587-5232
Email: managingeventos@uol.com.br
Website: http://www.diahome.org/DIAHOME/Education/FindEducationalOffering.aspx?productID=23627&eventType=Meeting
10th - 11th November 2010 at the Window Conference Centre in London, UK [2817]
Technology Transfer
This 2-day interactive workshop is intended to provide an overview of the challenges that must be overcome in transferring technology and to highlight some proven techniques for overcoming those challenges.
Contact: Judy Callanan
Telephone: +44 20 7193 7703; Fax: +44 20 7681 3582
Email: judy@pharma-training-courses.com
Website: http://pharma-training-courses.com/technology-transfer-for-pharmaceutical-products.html
10th - 11th November 2010 at the Window Conference Venue in London, UK [2815]
GMP Auditor Training
The key to effective internal auditing of suppliers is the training of both auditors and auditees in the purpose and relevant techniques of the audit and how these techniques can be channelled to achieve business and compliance improvements. It will cover Auditing Basics, Auditing Tools and Techniques, The Audit Process, Improving the Audit System, Added Value from Self Inspections (Level2 – QA Led)
Contact: Judy Callanan
Telephone: +44 20 7193 7703; Fax: +44 20 7681 3582
Email: judy@pharma-training-courses.com
Website: http://www.pharmatrainingservices.com/GMPAuditorTraining.htm
10th - 12th November 2010 in Dublin, Ireland [3029]
The CTD/eCTD: Building the Marketing Application throughout Clinical Development
Contact: Michael Roberts
Telephone: 610-688-1708
Email: info@cfpie.com
Website: http://www.cfpie.com/showitem.aspx?productid=078&source=pharmacy
10th - 12th November 2010 in King of Prussia, PA, USA [3030]
The Drug Development Process – From Discovery to Commercialization
Contact: Michael Roberts
Telephone: 610-688-1708
Email: info@cfpie.com
Website: http://www.cfpie.com/showitem.aspx?productid=025&source=pharmacy
10th - 11th November 2010 in King of Prussia, PA, USA [3031]
Sterilization Procedures: Technology, Equipment & Validation
Contact: Michael Roberts
Telephone: 610-688-1708
Email: info@cfpie.com
Website: http://www.cfpie.com/showitem.aspx?productid=075&source=pharmacy
11th - 12th November 2010 in King of Prussia, PA, USA [3032]
Preparing the CMC Section for NDAs/CTDs/INDs
Contact: Michael Roberts
Telephone: 610-688-1708
Email: info@cfpie.com
Website: http://www.cfpie.com/showitem.aspx?productid=061&source=pharmacy
12th November 2010 at the Window Conference Centre in London, UK [2816]
How to Audit API Manufacturers
This one day seminar is aimed at QA staff in drug products manufacturers and especially their QPs who have specific responsibilities under directive 2004/27/EC. Participants will learn about the legislators’ perspectives and the key differences between APIs and products, which lead to different audit techniques and thought processes when auditing API manufacturers.
Contact: Judy Callanan
Telephone: +44 20 7193 7703; Fax: +44 20 7681 3582
Email: judy@pharma-training-courses.com
Website: http://www.pharmatrainingservices.com/HowtoauditAPIManufacturers.htm
15th - 16th November 2010 at the Loews Phialdelphia hotel in Philadelphia, PA [2969]
Pharmaceutical Packaging Leadership Summit
By joining together leaders and innovators from the packaging, labeling and pharmaceutical industries, Opal Events will strive to offer it\\\'s guests the most up to date and important information on regulatory issues, new technologies, and possible partnerships.
Contact: pete jackson
Email: marketing@opalevents.org
Website: http://www.opalevents.org/conferencehtml/2010/pharmaceutical_packaging_leadership_summit_2010/pharmaceutical_packaging_leadership_summit.php
15th - 17th November 2010 in King of Prussia, PA, USA [3033]
Good Clinical Practices (GCP)
Contact: Michael Roberts
Telephone: 610-688-1708
Email: info@cfpie.com
Website: http://www.cfpie.com/showitem.aspx?productid=039&source=pharmacy
15th - 16th November 2010 in King of Prussia, PA, USA [3034]
Latin America - Understanding Regulatory Compliance Requirements
Contact: Michael Roberts
Telephone: 610-688-1708
Email: info@cfpie.com
Website: http://www.cfpie.com/showitem.aspx?productid=055&source=pharmacy
16th - 17th November 2010 in King of Prussia, PA, USA [3035]
Pharmaceutical Water Systems: Contemporary Technology & Compliance
Contact: Michael Roberts
Telephone: 610-688-1708
Email: info@cfpie.com
Website: http://www.cfpie.com/showitem.aspx?productid=093&source=pharmacy
17th - 18th November 2010 in King of Prussia, PA, USA [3036]
Japan - Regulatory Filing Requirements and Compliance Processes for Life Sciences
Contact: Michael Roberts
Telephone: 610-688-1708
Email: info@cfpie.com
Website: http://www.cfpie.com/showitem.aspx?productid=053&source=pharmacy
18th - 19th November 2010 in King of Prussia, PA, USA [3037]
Effective Risk-Based Applications of Drug cGMPs and Validation Requirements for Cosmetics and OTC Drug Products
Contact: Michael Roberts
Telephone: 610-688-1708
Email: info@cfpie.com
Website: http://www.cfpie.com/showitem.aspx?productid=037&source=pharmacy
23rd November 2010 at the Radisson Edwardian New Providence Wharf London in London,, UK [2876]
Joint DIA/EMA Variations Conference
See website for details
Event Code:
10109
Contact: DIA Europe
Telephone: 41 61 225 51 51
Email: DIAEUROPE@DIAEUROPE.ORG
Website: http://www.diahome.org/DIAHOME/Education/FindEducationalOffering.aspx?productID=23683&eventType=Meeting
26th November 2010 at the De Vere Venues in London, UK [3082]
European Medicines Agency - ENCePP Information Day
(ENCePP) is a project led by the European Medicines Agency (EMA) to bring together the available expertise and research experience in the fields of Pharmacoepidemiology and Pharmacovigilance scattered across Europe in a Network of Excellence, comprising research and medical-care centres, healthcare databases, electronic registries and existing networks.
Event Code:
10115
Contact: DIA Europe
Telephone: 41 61 225 51 51
Email: DIAEUROPE@DIAEUROPE.ORG
Website: http://www.diahome.org/DIAHome/Education/FindEducationalOffering.aspx?productID=24003&eventType=Meeting
29th - 30th November 2010 at the Marriott West India Quay in London, UK [2828]
2nd Joint DIA/ European Medicines Agency Innovation Forum: Is the EU Regulatory Framework Ready?
The 2nd Innovation forum will provide an opportunity to address the progress of innovative medicines in legal, organisational and technical aspects of the pharmaceutical framework in Europe. It will address the implementation of the EMA/CHMP think-tank report on innovative medicines and look at the direction of the Agency’s road map 2015. This forum will involve stakeholders such as patient representatives, academia delegates, regulators and industry scientists.
Event Code:
10105
Contact: DIA EUROPE
Telephone: 41 61 225 51 51
Email: DIAEUROPE@DIAEUROPE.ORG
Website: http://www.diahome.org/DIAHOME/Education/FindEducationalOffering.aspx?productID=22643&eventType=Meeting
30th November - 1st December 2010 in King of Prussia, PA, USA [3038]
Selecting and Managing CROs
Contact: Michael Roberts
Telephone: 610-688-1708
Email: info@cfpie.com
Website: http://www.cfpie.com/showitem.aspx?productid=086&source=pharmacy
30th November 2010 at the Online Event in Palo Alto,CA, USA [3098]
Why and How - Verification of Compendial Methods - USP (1226)
This verification of Compendial methods webinar training will discuss the requirements of USP (1226), what are FDA expectations related to method verification.
Contact: admin
Telephone: +1-650-620-3915; Fax: +1-650-963-2556
Email: admin@complianceonline.com
Website: http://www.complianceonline.com/ecommerce/control/trainingFocus/~product_id=701752?channel=pharmorg
1st - 3rd December 2010 at the Marriott Rive Gauche in Paris, , France [3062]
Practical Guide for Pharmacovigilance: Clinical Trials and Post Marketing
This is a basic overview course, intended for individuals who have limited experience in pharmacovigilance/drug safety monitoring. The focus will be on pharmacovigilance with traditional medicinal products, both investigational and marketed, intended for human use in clinical trials, in post marketing studies, and in the healthcare setting following product launch.
Event Code:
10526
Contact: DIA Europe
Telephone: 41 61 225 51 51
Email: DIAEUROPE@DIAEUROPE.ORG
Website: http://www.diahome.org/DIAHome/Education/FindEducationalOffering.aspx?productID=21872&eventType=Training%20Course
1st - 3rd December 2010 at the Hotel Le Meridien in Nice, France [2711]
11th Conference on European Electronic Document Management
Electronic gateways and advanced submission standards such as CDISC and RPS that extend the capabilities and flexibility of information exchange, new approaches for Enterprise Information Management, simpler and more affordable tools allowing compliant EDM for small corporations, collaborative and component-based authoring and new, powerful user interfaces are only some of the emerging novelties.
Contact: DIA EUROPE
Email: DIAEUROPE@DIAEUROPE.ORG
Website: http://www.diahome.org/DIAHOME/Education/FindEducationalOffering.aspx?productID=23224&eventType=Meeting
1st - 3rd December 2010 in Costa Mesa, CA, USA [3039]
Good Manufacturing Practices
Contact: Michael Roberts
Telephone: 610-688-1708
Email: info@cfpie.com
Website: http://www.cfpie.com/showitem.aspx?productid=113&source=pharmacy
1st - 3rd December 2010 in King of Prussia, PA, USA [3040]
Technical Writing for Pharmaceutical, Medical Device and Biotech Industries
Contact: Michael Roberts
Telephone: 610-688-1708
Email: info@cfpie.com
Website: http://www.cfpie.com/showitem.aspx?productid=077&source=pharmacy
2nd - 3rd December 2010 in Costa Mesa, CA, USA [3041]
Clinical Trial Design for Medical Devices
Contact: Michael Roberts
Telephone: 610-688-1708
Email: info@cfpie.com
Website: http://www.cfpie.com/showitem.aspx?productid=014&source=pharmacy
2nd - 3rd December 2010 in King of Prussia, PA, USA [3042]
Drug Master Files (DMFs) - Understanding and Meeting Your Regulatory and Processing Responsibilities
Contact: Michael Roberts
Telephone: 610-688-1708
Email: info@cfpie.com
Website: http://www.cfpie.com/showitem.aspx?productid=026&source=pharmacy
2nd - 3rd December 2010 in Costa Mesa, CA, USA [3043]
Preparation of FDA Submissions (INDs, NDAs, BLAs, ANDAs, Post-Approval Supplements) and Communicating with the FDA
Contact: Michael Roberts
Telephone: 610-688-1708
Email: info@cfpie.com
Website: http://www.cfpie.com/showitem.aspx?productid=085&source=pharmacy
3rd - 4th December 2010 at the Civil Law Auditorium, University of Santo Tomas in Manila, Philippines [3083]
3rd Philippine Pharmaceutical Research Congress 2010
The Congress which is the first of its kind in the Philippines, is in line with the Quadricentennial Celebrations of the Royal, Pontifical and Catholic university of Santo Tomas. It will bear the theme: Trends, Innovations and Entrepreneurship- Connecting TIEs in Pharmacy.
Contact: Aristea Bayquen
Telephone: 0063 2 4061611 loc 8223; Fax: 0063 2 7314040
Email: pprcust@yahoo.com
Website: http://www.pprcust.org/
5th - 7th December 2010 at the Radisson BLU Hotel, Dubai Deira Creek in Dubai, UAE [3063]
CTD Dossier Requirements: Focus on EU Module 1 and Quality Module 3
High Quality of a registration dossier facilities the registration procedure - Essential for Generics!
Contact: DIA Europe
Telephone: 41 61 225 51 51
Email: DIAEUROPE@DIAEUROPE.ORG
Website: http://www.diahome.org/DIAHome/Education/FindEducationalOffering.aspx?productID=22384&eventType=Training%20Course
6th - 8th December 2010 in India, India [2801]
BioPharma India Convention 2010
BioPharma India Convention 2010 is uniquely positioned as the only strategic event in India where global and Indian pharmaceutical companies, biotechs, CMOs, CROs, academic institutions and many others come together to assess the latest trends, partnerships and solutions.
It will also be held together with World Pharma Trials India 2010, Biologic Manufacturing World India 2010 and R&D Partnering World India 2010.
Contact: Esther Chan
Telephone: +65 6322 2742
Email: esther.chan@terrapinn.com
Website: http://www.terrapinn.com/2010/biopharmaindia/
6th - 8th December 2010 at the Grand Hyatt in Mumbai, India [3067]
Biologic Manufacturing World India 2010
Biologic Manufacturing World India is the only event in India where senior level executives from global and Indian biopharmas share their best practices in biologic manufacturing technology applications and outsourcing strategies.
Contact: Chua Yee Ling
Telephone: +65 6322 2757
Email: yeeling.chua@terrapinn.com
Website: http://www.terrapinn.com/2010/biologicindia/
6th - 8th December 2010 at the Grand Hyatt in Mumbai, India [3068]
8th Annual Drug Discovery World India 2010
Drug Discovery World India is designed to facilitate collaboration and technology transfer for scientists, researchers, R&D executives and clinicians from research institutions, pharmas, biotechs and CROs in India.
Contact: Chua Yee Ling
Telephone: +65 6322 2757
Email: yeeling.chua@terrapinn.com
Website: http://www.terrapinn.com/2010/drugindia/
6th - 8th December 2010 in King of Prussia, PA, USA [3044]
cGMP Quality Principles for Pharmaceuticals, Biopharmaceuticals, Biologics and Medical Devices
Contact: Michael Roberts
Telephone: 610-688-1708
Email: info@cfpie.com
Website: http://www.cfpie.com/showitem.aspx?productid=095&source=pharmacy
6th - 7th December 2010 in Costa Mesa, CA, USA [3045]
Stability Programs for Product Shelf Life - From Development to Approval
Contact: Michael Roberts
Telephone: 610-688-1708
Email: info@cfpie.com
Website: http://www.cfpie.com/showitem.aspx?productid=072&source=pharmacy
8th December 2010 at the Drug Information Association, Inc. in Horsham, PA, USA [3064]
Overview of Drug Development
Participate in interactive discussions on how to develop drugs and biologics under FDA and ICH Guidelines while proactively overcoming any drug development challenges.
Event Code:
10430
Contact: Colleen Buckley
Telephone: 215-442-6108
Email: Colleen.Buckley@diahome.org
Website: http://www.diahome.org/DIAHome/Education/FindEducationalOffering.aspx?productID=21430&eventType=Training%20Course
8th - 9th December 2010 at the Monitor website for venue info in Washington, DC, USA [3066]
US and International Prescription Drug Labeling Comparisons and Important Updates
Join Regulatory Authorities from Different Regions to Discuss Key Labeling Requirements, Recommendations, Trends, and New Developments
Contact: Wendy Moyer
Telephone: 215.293.5810
Email: email Wendy.Moyer@diahome.org
Website: http://www.diahome.org/DIAHome/Education/FindEducationalOffering.aspx?productID=24058&eventType=Meeting
8th - 10th December 2010 in King of Prussia, PA, USA [3046]
Root Cause Analysis for CAPA
Contact: Michael Roberts
Telephone: 610-688-1708
Email: info@cfpie.com
Website: http://www.cfpie.com/showitem.aspx?productid=069&source=pharmacy
8th - 9th December 2010 in King of Prussia, PA, USA [3047]
Software Development for Medical Device Professionals
Contact: Michael Roberts
Telephone: 610-688-1708
Email: info@cfpie.com
Website: http://www.cfpie.com/showitem.aspx?productid=071&source=pharmacy
8th - 10th December 2010 in Costa Mesa, CA, USA [3048]
The CTD/eCTD: Building the Marketing Application throughout Clinical Development
Contact: Michael Roberts
Telephone: 610-688-1708
Email: info@cfpie.com
Website: http://www.cfpie.com/showitem.aspx?productid=078&source=pharmacy
9th December 2010 at the Swissôtel Zurich in Zurich, Switzerland [3065]
eCTD Submissions in Switzerland
Since January 2010, Swissmedic accepts electronic-only submissions in eCTD-format. This course will
offer insight into the compilation of the eCTD, share experience and best practice gained during eCTD
submissions in Switzerland, and the eCTD review process. The focus will be on practical experience
gained in preparing and submitting eCTDs to Swissmedic.
Contact: DIA Europe
Telephone: 41 61 225 51 51
Email: DIAEUROPE@DIAEUROPE.ORG
Website: http://www.diahome.org/DIAHome/Education/FindEducationalOffering.aspx?productID=23713&eventType=Training%20Course
13th - 14th December 2010 in King of Prussia, PA, USA [3049]
Good Clinical Practice for Medical Device Investigations
Contact: Michael Roberts
Telephone: 610-688-1708
Email: info@cfpie.com
Website: http://www.cfpie.com/showitem.aspx?productid=122&source=pharmacy
13th - 14th December 2010 in King of Prussia, PA, USA [3050]
Overview of FDA Regulatory Compliance for Medical Devices
Contact: Michael Roberts
Telephone: 610-688-1708
Email: info@cfpie.com
Website: http://www.cfpie.com/showitem.aspx?productid=020&source=pharmacy
15th - 16th December 2010 in King of Prussia, PA, USA [3051]
Good Clinical Practice Auditing
Contact: Michael Roberts
Telephone: 610-688-1708
Email: info@cfpie.com
Website: http://www.cfpie.com/showitem.aspx?productid=121&source=pharmacy
27th - 28th January 2011 at the Tower Hall Funabori in Tokyo, Japan [3103]
14th Annual Workshop in Japan for Clinical Data Management
See website for detailed description.
Event Code:
11301
Contact: Keiko Cambridge
Telephone: 81-3-5833-8444
Email: keiko.cambridge@diajapan.org
Website: http://www.diahome.org/DIAHome/Education/FindEducationalOffering.aspx?productID=23771&eventType=Meeting
1st - 2nd February 2011 at the Hilton Parsippany Hotel in Parsippany, NJ, USA [3081]
2011 Pharma Market Research Conference
The Pharma Market Research Conference on February 1-2, 2011 at the Hilton Parsippany Hotel in New Jersey is the premier gathering for senior level pharmaceutical, biotech, medical device, and diagnostic executives in market and marketing research. More than 200 people came in 2010! The Pharma Market Research Conference is your exclusive entry into the world of pharmaceutical market research.
Contact: Amy Yueh
Email: info@pharmamarketresearchconference.com
Website: http://www.pharmamarketresearchconference.com
7th - 9th February 2011 at the Washington Hilton Hotel in Washington, DC, USA [3102]
CMC Workshop: Translating Science into Successful Regulatory Submissions
This CMC workshop will feature cross-functional discussions on science and risk-based approaches to drug development and manufacturing, drug substance and drug product specifications, genotox impurities, global stability studies, and post-approval changes.
Event Code:
11010
Contact: Rachel Minnick
Telephone: 215.442.6131
Email: Rachel.Minnick@diahome.org
Website: http://www.diahome.org/DIAHome/Education/FindEducationalOffering.aspx?productID=23878&eventType=Meeting
14th - 17th February 2011 at the Gaylord National Hotel and Convention Center in National Harbor, MD, USA [3104]
Electronic Document Management 2011: The Intersection of Data, Documents and Submissions
Join industry, regulatory and support organization experts in discussions on the nexus of data, document management and submissions
* Excellent opportunity to network with colleagues from industry, regulatory and support organizations
* Exhibit hall with 30 exhibit booths
Event Code:
11003
Contact: Joanne Wallace
Telephone: 215.442.6180
Email: Joanne.Wallace@diahome.org
Website: http://www.diahome.org/DIAHome/Education/FindEducationalOffering.aspx?productID=23833&eventType=Meeting
28th - 31st March 2011 at the Marina Bay Sands in Singapore, Singapore [3073]
4th Annual BioPharma Asia Convention 2011
BioPharma Asia Convention 2011 is uniquely positioned as Asia\\\'s only exhibition that showcases leading technocrats, solution and service suppliers across the entire value chain of the biopharma industry in Asia!
Contact: Chua Yee Ling
Telephone: +65 6322 2757
Email: yeeling.chua@terrapinn.com
Website: http://www.terrapinn.com/2011/biopharmaasia/
28th - 31st March 2011 at the Marina Bay Sands in Singapore, Singapore [3069]
4th Annual Biologic Manufacturing World Asia 2011
Biologic Manufacturing World Asia will be the only event in Asia where senior level executives from global and Asian biopharmas share their best practices in biologic manufacturing technology applications and outsourcing strategies.
Contact: Chua Yee Ling
Telephone: +65 6322 2757
Email: yeeling.chua@terrapinn.com
Website: http://www.terrapinn.com/2011/biologicasia/
28th - 31st March 2011 at the Marina Bay Sands in Singapore, Singapore [3070]
4th Annual Drug Discovery World Asia 2011
Drug Discovery World Asia 2011 is a strategic and scientific conference for discussing innovation, technology and partnership in driving drug discovery and pre-clinical development in Asia
Contact: Chua Yee Ling
Telephone: +65 6322 2757
Email: yeeling.chua@terrapinn.com
Website: http://www.terrapinn.com/2011/drugdiscovery/
28th - 31st March 2011 at the Marina Bay Sands in Singapore, Singapore [3071]
4th Annual Pharma Partnering & Investment World Asia 2011
Pharma Partnering World Asia 2011 will bring together pharmas, start-up & spin-off biotechs, research and academic institutions, professional investors, contract research service providers to network and evaluate partnering opportunities in Asia.
Contact: Chua Yee Ling
Telephone: +65 6322 2757
Email: yeeling.chua@terrapinn.com
Website: http://www.terrapinn.com/2011/partneringasia/
28th - 31st March 2011 at the Marina Bay Sands in Singapore, Singapore [3072]
4th Annual Pharma Trials World Asia 2011
Pharma Trials World Asia brings together global and Asian pharmas, biotechs, CROs and clinical trial solution providers to explore effective and efficient clinical trial development in Asia.
Contact: Chua Yee Ling
Telephone: +65 6322 2757
Email: yeeling.chua@terrapinn.com
Website: http://www.terrapinn.com/2011/pharmatrials/
28th - 30th March 2011 at the Palexpo in Geneva, Switzerland [3085]
DIA 23rd Annual EuroMeeting
The EuroMeeting attracts more than 3,000 professionals from over 50 countries. It brings together professionals from the biopharmaceutical industry, contract service organisations, clinical research, regulatory agencies, health ministries, patients’ organisations and universities. This convergence affords attendees the opportunity to network with professional colleagues from around the world.
Event Code:
11101
Contact: DIA Europe
Telephone: 41 61 225 51 51
Email: diaeurope@diaeurope.org
Website: http://www.diahome.org/DIAHome/FlagshipMeetings/Home.aspx?meetingid=23313
28th - 31st March 2011 at the Marina Bay Sands in Singapore, Singapore [3074]
4th Annual BioIT World Asia 2011
Bio IT World Asia is a strategic and scientific conference where global and Asian pharmas, biotechs, research and academic institutes and solution providers discuss the latest enabling technologies and research breakthroughs that impact drug discovery pipeline.
Contact: Chua Yee Ling
Telephone: +65 6322 2757
Email: yeeling.chua@terrapinn.com
Website: http://www.terrapinn.com/2011/bioit
30th March - 1st April 2011 at the Austria Center Vienna in Vienna, Austria [2881]
16th Congress of the EAHP
Congress Focus: Hospital Pharmacists in a changing world - opportunities and challenges.
Contact: Annalisa Gardella
Telephone: 0032-2-741.24.36
Email: ea@eahp.eu
Website: http://www.eahp.eu/Congresses/2011-Congress-Vienna-Austria
Last update: Tue 31 Aug 2010 10:57:25 am