23rd April 2008 - 25th April 2008 at the Venue: To be announced
in Nice, France [1770]
BIOTECHNOLOGY FOR THE NON BIOTECHNOLOGIST
The purpose of this training course is to provide Non-Biotechnologists with the basic theory to understand Principles, Techniques and the Potentials of Biotechnology. Biotechnology combines disciplines such as Molecular Biology, Biochemistry, Chemistry, Microbiology, Chemistry, Microbiology, Chemical Engineering and Computing. This rapidly advancing science offers new and exciting opportunities to mankind, especially in the fight against disease.
Contact: Judith Black / Leigh White
Telephone: +44 1483 730071; Fax: +44 1483 730008
Email: info@management-forum.co.uk; leighwhite@ntlworld.com
Website: http://www.management-forum.co.uk/html/con_semin_section/con_display_event.asp?event=680
24th April 2008 - 25th April 2008 at the The Rembrandt Hotel
in London, United Kingdom [1888]
BASIC PCT FORMALITIES COURSE - For Patent Administrators and Formalities Staff
The purpose of this seminar is to inform the participants how to prepare an international filing under the PCT and how subsequently to monitor the consecutive procedural steps, time-limits and payment of fees under the PCT internaational phase, in designated and elected states.
Contact: Judith Black/Leigh White
Telephone: +44 1483 730071; Fax: +44 1483 730008
Email: info@management-forum.co.uk; leighwhite@ntlworld.com
Website: http://www.management-forum.co.uk/html/con_semin_section/con_display_event.asp?event=100
24th April 2008 at the EMEA in Canary Wharf, London, United Kingdom [2002]
EudraVigilance: Medicinal Product Dictionary
The EMEA has prepared this special EudraVigilance Medicinal Product Dictionary (EVMPD) course in the light of the implementation of the EU Directive on Clinical Trials (Directive 2001/20/EC).
This EVMPD course is addressing specifically all aspects related to the regulatory background, the definitions and procedures and the technical specifications for the handling and maintenance of IMP data and authorised medicinal product data in the EVMPD by the Sponsor or the MAH.
Participants will receive a training certificate that will allow them to register with EudraVigilance and to enter and maintain IMP and authorized medicinal product data in the EVMPD.
Contact: Senior Manager of Marketing
Telephone: +41 61 225 51 51; Fax: +41 61 225 51 52
Email: diaeurope@diaeurope.org
Website: http://www.diahome.org
24th April 2008 at the Online in Online, USA [2061]
Site and Sponsor Recruitment Preparations Prior to the Investigator Meeting - Second in a Patient Recruitment Webinar Series
Many sponsors and CROs do not have clinical research associates with the expertise to conduct optimal site selection and site initiation. Sub-optimal site selection and inadequate training in enrollment and retention contribute to prolonged study enrollment and lower subject retention rates which increase both the cost and duration of the study. Any increase in the ability of sites to forecast, recruit, and retain a higher percentage of the original allocation of subjects will result in significant cost savings to a sponsor and a potential decrease in cycle time.
FEATURED TOPICS
* Successful recruitment planning,
* What to include in a site feasibility survey,
* Proactive recruitment planning and past performance analysis,
* Importance of market research,
* Site motivation analysis, and
* Developing recruitment solutions and the role of the clinical research associate.
Contact: Marketing Manager
Telephone: +1.215.442.6100; Fax: +1.215.442.6199
Email: dia@diahome.org
Website: http://www.diahome.org
25th April 2008 at the The Rembrandt Hotel in London, United Kingdom [1978]
PATENTING BIOSCIENCE INVENTIONS - The US and European Perspective
This seminar is designed to provide participants with a good understanding of the issues that may arise when working with bioscience related inventions. The seminar will be split into two distinct parts. The first part of the day will be lecture based and will focus on the differences between European and US practice. The second part of the day will feature practical workshops, designed to assist attorneys with claim drafting.
Contact: Judith Black / Leigh White
Telephone: +44 1483 730071; Fax: +44 1483 730008
Email: info@management-forum.co.uk, leighwhite@ntlworld.com
Website: http://www.management-forum.co.uk/html/con_semin_section/con_display_event.asp?event=817
28th April 2008 at the The Rembrandt Hotel in London, UK [2010]
OVERVIEW OF GCP - This course provides an Introduction or Refresher to GCP
Knowledge of GCP is essential to everyone working on clinical trials and those who work with clinical trial professionals. Regulatory inspectors now look for evidence that professionals working on clinical trials have received regular training in GCP and understand how to comply with GCP requirements. This is the case for both sponsor and study site professionals including investigators. This course will take you through the most important areas of GCP to help ensure that you will meet the more stringent inspection requirements that we now have in Europe. This compact course is delivered by an expert in GCP who makes the subject really interesting and stimulating. It is ideal as a GCP refresher as well as being excellent for those wanting an overview of GCP. It will also be particularly helpful for training investigators as evidence to regulatory inspectors that investigators are appropriately trained GCP. An optional on-line examination to assess your knowledge of GCP is also available, which can be used as further evidence of your competence during inspections.
Contact: Judith Black / Leigh White
Telephone: +44 1483 730071; Fax: +44 1483 730008
Email: info@management-forum.co.uk, leighwhite@ntlworld.com
Website: http://www.management-forum.co.uk/html/con_semin_section/con_display_event.asp?event=837
28th April 2008 - 29th April 2008 at the Loews Hotel in Philadelphia, PA, USA [2067]
2nd Clinical Supply Forecasting Summit
Effective clinical supply forecasting is the key to accelerating clinical trials and gaining the competitive advantage. Utilizing modeling, simulation and evaluation of key metrics to increase the accuracy of clinical supply forecasts, streamlines clinical development, minimizes operational costs, and reduces overall cycle times.
Now in its second year, Exl Pharma’s Clinical Supply Forecasting Summit provides an interactive forum for executives to present case study examples, share best practices and discuss strategies for gaining efficiencies through better clinical supply forecasting. Learn what techniques other companies are pursuing, compare ROIs on forecasting technologies and take-home applicable information to streamline clinical trials and reduce costs.
Contact: Kristen Hunter
Telephone: 212-400-6240; Fax:
Email: info@exlpharma.com
Website: http://www.exlpharma.com/eventDetail.php?id=110
28th April 2008 - 29th April 2008 at the Inter Continental The Grand Mumbai in Mumbai, Maharastra, India [2065]
DIA 1st Indian Annual Regulatory Conference Building Bridges Between the Regulators and the Pharmaceutical Industry: Indian Regulatory Landscape in the Next Decade
DIA 1st Indian Annual Regulatory Conference continues the DIA tradition of premier multidisciplinary, neutral, and international events.
This conference launches the establishment of a DIA office in Mumbai, and of the DIA provisional Advisory Council of India.
India has a strong need for an international forum that brings together industry, academia, and regulators to educate its drug development professionals on regulations, clinical practices, and safety standards that will impact the approval of drugs developed in India for a global market. Join regulators, industry representatives, and academia to share experiences and key objectives that will help to bridge the gap between regulators and industry over the next decade.
Contact: Marketing Manager
Telephone: +1.215.442.6100; Fax: +1.215.442.6199
Email: dia@diahome.org
Website: http://www.diahome.org
29th April 2008 at the The Rembrandt Hotel in London, United Kingdom [1988]
GCP UPDATE: REVIEW OF THE LATEST REQUIREMENTS IN EUROPE AND US
To ensure clinical trials meet the requirements of the regulatory authorities it is essential that trials are carried out to the latest GCP regulatory requirements. It is particularly important to keep up to date and be familiar with the recent developments in GCP, and also how these are likely to impact on trials in the future for both pharmaceutical companies and the study sites. Regulatory inspectors expect those involved in clinical trials to be updated with recent developments in GCP – this workshop will be ideal for this. This very informative workshop will take you through the most important recent developments which are having an impact on clinical trials. Topics include an update on the latest CT Directive guidelines and other EU GCP developments, and recent initiatives in the US which are having an impact in Europe. There will be plenty of time for group discussion of your issues so as to help you develop you strategies for managing these changes.
Contact: Judith Black / Leigh White
Telephone: +44 1483 730071; Fax: +44 1483 730008
Email: info@management-forum.co.uk, leighwhite@ntlworld.com
Website: http://www.management-forum.co.uk/html/con_semin_section/con_display_event.asp?event=711
30th April 2008 - 2nd May 2008 at the Embassy Suites Hotel at the Chevy Chase Pavilion in Washington,DC, USA [2003]
Essentials of Project Management
This course is intended for project managers and other biotech/pharmaceutical industry professionals having responsibility for the management or leadership of projects. You will learn the fundamentals of project management and how they can be applied to best meet the needs of projects. The course will include presentation, discussion and hands-on interactive practice of project management tools, techniques and methods in a biotech/pharmaceutical industry setting. You will take away an understanding of the project management process and a set of project management skills that can be immediately put to use in your work.
Contact: Marketing Manager
Telephone: +1.215.442.6100; Fax: +1.215.442.6199
Email: dia@diahome.org
Website: http://www.diahome.org
1st May 2008 - 2nd May 2008 at the Bridgewater Marriot in Bridgewater, NJ, USA [2069]
A Medical Affairs Leadership Conference
Contact: Ethan Denkensohn
Telephone: 212-400-6240; Fax:
Email: info@exlpharma.com
Website: http://www.exlpharma.com/eventDetail.php?id=107
1st May 2008 at the Royal Pharmaceutical Society of Great Britain in London, United Kingdon [1904]
Biologically-Active Compounds in Foods and Drinks
How healthy is 'healthy eating’? Many are confused about the scientific basis for many of the health claims made for common foods and drinks. Sales of ‘supplements’ are high but their use is controversial, since some consider them to be unnecessary if a proper diet is followed. The aim of this meeting is to consider how the biological activities of ingredients of common foods and drinks might explain their claimed benefits.
Contact: Gabriella Highfield
Telephone: 02075722640; Fax: 02075722506
Email: science@rpsgb.org
Website: http://www.rpsgb.org/pdfs/sciconf0805.pdf
5th May 2008 - 6th May 2008 at the Hotel Kong Arthur in Copenhagen, Denmark [2057]
Building the eCTD
This course will offer insight into the compilation of the eCTD, share experience and best practice 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.
Contact: Senior Manager of Marketing
Telephone: +41 61 225 51 51; Fax: +41 61 225 51 52
Email: diaeurope@diaeurope.org
Website: http://www.diahome.org/
5th May 2008 - 7th May 2008 at the Sheraton Inner Harbor Hotel in Baltimore, MD, USA [2028]
Regulatory Affairs Part II: The CTD/NDA Phase
This course will offer insight into the regulatory background of the NDA, outline how to prepare an NDA in CTD format, and review post-approval activities. The course will focus on drug and well-characterized biological products and not the regulatory process for devices, generic products or traditional biologics.
COURSE HIGHLIGHTS
* Overview, and roles and responsibilities of FDA
* NDA in CTD format
* Regulatory compliance and FDA inspections
* Post approval regulatory requirements for NDAs
* Regulatory requirements for prescription drug labeling
* Review of prescription drug/biologics advertising and promotional labeling.
Contact: Marketing Manager
Telephone: +1.215.442.6100; Fax: +1.215.442.6199
Email: dia@diahome.org
Website: http://www.diahome.org/
5th May 2008 at the DIA in Horsham, PA, USA [2026]
Good Clinical Practices for the Clinical Research Professional
With the goal of helping to ensure well-trained clinical investigators and study staff to conduct safe and effective clinical trials, this training course provides the basic knowledge required to conduct clinical trials, including knowledge about subject safety, regulations, and the practicalities of performing research studies. This one-day training course format is a compressed and streamlined lecture.
COURSE HIGHLIGHTS
* Roles and responsibilities of investigators, study staff, research institutions, and IRBs.
* Regulations and guidelines that govern clinical investigations.
* Practices that ensure effective and efficient study conduct.
Contact: Marketing Manager
Telephone: +1.215.442.6100; Fax: +1.215.442.6199
Email: dia@diahome.org
Website: http://www.diahome.org
5th May 2008 - 8th May 2008 at the Westin Horton Plaza in San Diego,CA, USA [2027]
The Leadership Experience
THE LEADERSHIP EXPERIENCE is a 3 1/2-day session in which participants, working in a group, assume senior management roles. They analyze information, make decisions, and deal with the consequences of their decisions. There is special emphasis on the skills required to establish cooperation, diagnose and correct dysfunctional groups, and combine the skills of multiple people to accomplish what cannot be done alone. This is a VERY intensive program designed for those who are serious about improving their leadership skills.
Contact: Marketing Manager
Telephone: +1.215.442.6100; Fax: +1.215.442.6199
Email: dia@diahome.org
Website: http://www.diahome.org/
5th May 2008 - 7th May 2008 at the EMEA in Canary Wharf, London, United Kingdom [2029]
Eudravigilance - Electronic Reporting of ICSRs in the EEA
This course will be the only training programme officially recognised by the EMEA. The EMEA will present successful candidates with a 'Certificate of Completion' based on a competency assessment at the end of the course.
The EudraVigilance training programme is open to Contract Research Organisations (CROs), Consultants and other organisations with an interest in the EudraVigilance project. However, it should be noted that the persons attending the training will only be given access the EudraVigilance training environment for a period of two months. After this period the EudraVigilance system will only be available for these organisations if they act on behalf of a Marketing Authorisation Holder (MAH) or a Sponsor of a Clinical Trial and that this is notified to the EMEA in writing and through the EudraVigilance registration process.
Contact: Senior Manager of Marketing
Telephone: +41 61 225 51 51; Fax: +41 61 225 51 52
Email: diaeurope@diaeurope.org
Website: http://www.diahome.org/
5th May 2008 - 7th May 2008 at the Sheraton University City in Philadelphia, PA, [2070]
3rd Annual Integrated Relationship Marketing and Sales for Pharma
ExL Pharma is proud to present our 3rd Annual Integrated Relationship Marketing and Sales for Pharma Conference -- Building on the success from the first two events, this year's conference will once again provide pivotal and innovative strategies to maximize your relationship marketing and sales efforts.
The first day will feature a sales force stradegy and technology seminar, coinciding with two patient adherence/compliance workshops. The second day will be dedicated to Integrated Relationship Marketing strategy and also provide presentations on multi-cultural marketing. The third day will feature two tracks – one on direct to patient and one on direct to physician marketing.
This is THE interactive marketing forum featuring pharmaceutical industry case studies, vendors presenting on capabilities to consider, and academics discussing the driving factors behind behavior.
Contact: Matt Millman
Telephone: 212-400-6240; Fax:
Email: info@exlpharma.com
Website: http://www.exlpharma.com/eventDetail.php?id=108
6th May 2008 - 7th May 2008 at the University of California, Washington Center in Washington,DC, USA [2030]
Improving Drug Development Using Patient Adherence Data in Clinical Trials
Data from trials and practice show that ambulatory patients frequently underdose, either by: never starting dosing, omitting scheduled doses, or premature cessation of dosing. Routine methods fail to detect most of these errors. Yet variable dosing histories are a major source of variance in drug response, confounding the interpretation of all dose/time-dependent trial outcomes, eg, estimates of PK parameters, dose-dependent efficacy, regimen definition, dose-dependent toxicity. Properly analyzed dosing histories can improve learning-phase trials.
FEATURED TOPICS
* Documenting and managing adherence in clinical trials
* Methods of compiling and assessing drug dosing histories
* Adherence-informed pharmacometric analysis of effectiveness
* Safety
* Dosage-regimen optimization
* Regulatory issues
* Labeling
* Statistical considerations
Contact: Marketing Manager
Telephone: +1.215.442.6100; Fax: +1.215.442.6199
Email: dia@diahome.org
Website: http://www.diahome.org/
7th May 2008 - 9th May 2008 at the Keio Plaza Hotel * Tokyo, Japan in Tokyo, Japan [2035]
IBC’s 3rd Annual International Conference and Exhibition Drug Discovery Development of Innovative Therapeutics JAPAN
IBC’s 3rd annual Drug Discovery & Development of Innovative Therapeutics JAPAN, has been designed specifically for scientific research and R&D professionals, business developers and licensing executives, and research planning and corporate strategists who are trying to accelerate the discovery and development of innovative therapeutic. Don’t’ Miss the ONLY conference in Japan to provide BOTH cutting-edge updates on the scientific strategies needed AND the opportunity to pre-arrange meetings with other attendees for one-on-one partner meetings.
Contact: IBC Customer Service
Telephone: (800) 390-4078; Fax: (941) 365-0104
Email: reg@ibcusa.com
Website: http://www.IBCLifeSciences.com/japan
7th May 2008 - 8th May 2008 at the The Rembrandt Hotel in London, United Kingdom [1979]
CONDUCTING PRE AND POST MARKET MEDICAL DEVICE CLINICAL STUDIES - A repeat of this successful course
This course has been designed specifically for those involved in pre and post market studies within the medical device industry. The device development process can be complex, costly and can take many years to complete. The collection of clinical data to demonstrate safety and performance of a device is pivotal to the development process and necessary for regulatory approval. The collection of post market data is a key aspect of continued safety and performance considerations once the device is on the market. This course will cover the full range of clinical research activities that should be applied during the collection of data for both pre and post market studies. It will provide delegates with information on the European regulations for conducting medical device studies and help them to run studies in Europe. Delegates should benefit from the advice and tips on the practicalities of conducting medical device studies. There will be ample time for case studies and group discussions.
Contact: Judith Black / Leigh White
Telephone: +44 1483 730071; Fax: +44 1483 730008
Email: info@management-forum.co.uk, leighwhite@ntlworld.com
Website: http://www.management-forum.co.uk/html/con_semin_section/con_display_event.asp?event=816
8th May 2008 - 9th May 2008 at the The Rembrandt Hotel in London, United Kingdom [1934]
FUNDAMENTALS of EUROPEAN CLAIM DRAFTING - A practical course
The seminar is designed to provide the participants with a good understanding of the basic claim drafting process with a view to successfully preparing and defending claims according to European practice. Emphasis will be placed on achieving adequate protection while meeting official requirements. The course is designed for experienced Patent Attorneys, and trainees with at least one year's experience, who want to develop their drafting skills and understand the fundamentals of European claim drafting.
Contact: Judith Black / Leigh White
Telephone: +44 1483 730071; Fax: +44 1483 730008
Email: info@management-forum.co.uk, leighwhite@ntlworld.com
Website: http://www.management-forum.co.uk/html/con_semin_section/con_display_event.asp?event=107
8th May 2008 - 9th May 2008 at the The Rembrandt Hotel in London, UK [2048]
DESIGN AND CONDUCT OF CLINICAL TRIALS IN RESPIRATORY MEDICINE - Expert Overview of the Key Aspects
This meeting will present expert detailed overviews of key aspects of the design and conduct of clinical trials with respiratory disorders including asthma, COPD, lung fibrosis and paediatric conditions Topics covered include study design, regulatory guidelines, pharmacogenetics, safety assessment and the value of animal experiments. This programme will be invaluable for all those involved in clinical trials in respiratory medicine, including pharmacologists, clinical development staff, trial monitors and project managers in the pharmaceutical industry, regulatory personnel and clinical investigators in hospitals, general practice and academic centres
Contact: Judith Black / Leigh White
Telephone: +44 1483 730071; Fax: +44 1483 730008
Email: info@management-forum.co.uk, leighwhite@ntlworld.com
Website: http://www.management-forum.co.uk/html/con_semin_section/con_display_event.asp?event=831
8th May 2008 - 9th May 2008 at the The Café Royal in London, United Kingdom [2011]
PRE-FILLED SYRINGES - 2nd Annual Conference
Full details to follow. Please contact for a brochure: info@management-forum.co.uk
Contact: Judith Black / Leigh White
Telephone: +44 1483 730071; Fax: +44 1483 730008
Email: info@management-forum.co.uk, leighwhite@ntlworld.com
Website: http://www.management-forum.co.uk/html/con_semin_section/con_display_event.asp?event=808
13th May 2008 at the Sheraton National Hotel Arlington in Arlington, VA, USA [2082]
Digital Signatures: Practical Strategies for Life Science Organizations
Achieve Fully Electronic Business-to-regulator and Business-to-business Processes
Standards-based electronic signatures (Digital Signatures) are essential to electronic submissions in compliance with FDA 21 CFR Part 11. However, for the biopharmaceutical industry, the benefits of digital signatures extend beyond compliance requirements to accelerated decision making, approval processes, cost reductions, and more efficient and paperless operations.
HIGHLIGHTS
* Strategies to facilitate the adoption of digital signatures for organizations of every size
* Case studies from organizations that have successfully implemented digital signature applications for processes, including:
-Internal quality and clinical operations
-Large web-based business-to-business portals
-Cross-organizational workflows
* Presentations and discussion by industry thought leaders from biopharmaceutical companies, CROs, and technology providers.
Contact: Marketing Manager
Telephone: +1.215.442.6100; Fax: +1.215.442.6199
Email: dia@diahome.org
Website: http://www.diahome.org
13th May 2008 at the The Rembrandt Hotel in London, UK [1989]
DRAFTING INTERNATIONAL INTELLECTUAL PROPERTY AGREEMENTS
This successful seminar will focus on the drafting skills and legal and commercial issues to be considered when drawing up international intellectual property agreements, confidentiality agreements, material transfer agreements, term sheets, intellectual property licenses and assignments and general IP terms in R&D contracts. The day will include practical exercises to consolidate learning.
Contact: Judith Black / Leigh White
Telephone: +44 1483 730071; Fax: +44 1483 730008
Email: info@management-forum.co.uk, leighwhite@ntlworld.com
Website: http://www.management-forum.co.uk/html/con_semin_section/con_display_event.asp?event=819
13th May 2008 - 14th May 2008 at the DIA in Horsham, PA, USA [2031]
Resource Management at the Functional and Enterprise Levels
Learn how to build, implement, and maintain a Resource Management business system, as well as accommodate the reverberations of the cultural change and how to get buy-in from all the key stakeholders.
COURSE HIGHLIGHTS
* The Resource Management Business System
* Linking the Resource Management System with Portfolio, Functional and Project Management Systems
* Building and Implementing a Resource Management System
* Sustaining a Resource Management System after Implementation
* Roles and Responsibilities
* Handling Cultural Changes.
Contact: Marketing Manager
Telephone: +1.215.442.6100; Fax: +1.215.442.6199
Email: dia@diahome.org
Website: http://www.diahome.org
14th May 2008 - 15th May 2008 at the The Rembrandt Hotel
in London, United Kingdom [2049]
US REIMBURSEMENT FOR MEDICAL DEVICES
Obtaining adequate payments for your customers requires a strategy that addresses all stakeholders and employs well-defined tactics. Medicare is the largest insurer in the US and has the most influence, but represents only one piece of the payment puzzle. The US healthcare system also has a large number of private insurance programs; the goal is to obtain reimbursement from all of them. To do so, medical device manufacturers must work with myriad stakeholders to influence reimbursement. This course will teach you who to work with, what tactics and data to use and how to fashion the winning reimbursement strategy.
Contact: Judith Black / Leigh White
Telephone: +44 1483 730071; Fax: +44 1483 730008
Email: info@management-forum.co.uk, leighwhite@ntlworld.com
Website: http://www.management-forum.co.uk/html/con_semin_section/con_display_event.asp?event=847
14th May 2008 - 16th May 2008 at the Eurosites Paris Rivoli in Paris, France [2083]
EudraVigilance - Electronic Reporting of ICSRs in the EEA
This course will be the only training programme officially recognised by the EMEA. The EMEA will present successful candidates with a 'Certificate of Completion' based on a competency assessment at the end of the course.
The EudraVigilance training programme is open to Contract Research Organisations (CROs), Consultants and other organisations with an interest in the EudraVigilance project. However, it should be noted that the persons attending the training will only be given access the EudraVigilance training environment for a period of two months. After this period the EudraVigilance system will only be available for these organisations if they act on behalf of a Marketing Authorisation Holder (MAH) or a Sponsor of a Clinical Trial and that this is notified to the EMEA in writing and through the EudraVigilance registration process.
Contact: Senior Manager of Marketing
Telephone: +41 61 225 51 51; Fax: +41 61 225 51 52
Email: diaeurope@diaeurope.org
Website: http://www.diahome.org/DIAHOME/Education/FindEducationalOffering.aspx?productID=16980&eventType=Eudr
15th May 2008 at the The Rembrandt Hotel in London, United Kingdom [1980]
PATENT PRACTICE IN INDIA - Special fee reduction for delegates attending this seminar AND Patent Practice in China on May 16 (Ref. H5-3208)
This seminar will provide delegates with overall information about Indian patent practice, while especially pointing out the important features characteristic to Indian patent law and practice as compared with European and US patent practices. The programme examines routes of application, patentability, claim drafting, infringement, enforcement and litigation, and will also examine recent developments and changes in Indian patent law and practice.
Contact: Judith Black / Leigh White
Telephone: +44 1483 730071; Fax: +44 1483 730008
Email: info@management-forum.co.uk, leighwhite@ntlworld.com
Website: http://www.management-forum.co.uk/html/con_semin_section/con_display_event.asp?event=396
15th May 2008 at the The Cavendish Hotel in London, United Kingdom [2012]
THE EU RISK MANAGEMENT PLAN THEORY & PRACTICE
This seminar will explain the regulatory requirements for the Risk Management Plan, and offer practical advice for its development and implementation
Contact: Judith Black / Leigh White
Telephone: +44 1483 730071; Fax: +44 1483 730008
Email: info@management-forum.co.uk, leighwhite@ntlworld.com
Website: http://www.management-forum.co.uk/html/con_semin_section/con_display_event.asp?event=829
15th May 2008 - 16th May 2008 at the The Rembrandt Hotel in London, United Kingdom [2013]
APIs: CERTIFY YOUR ACTIVE SUBSTANCES AS GMP COMPLIANT - Have you really grasped the DIFFERENCE between PRODUCTS and APIs?
This two-day Training Course will attempt to clarify: The Requirements for GMP Compliance of API Manufacturers, The Regulatory Expectations of the MA holder, The role of the QP. The expert panel of speakers will guide you in: Developing Sourcing Strategies for APIs, GMP-Relevant Activities for API Manufacture, Maximising Benefits from Auditing an API Site, How to deal with Non-Compliance Issues that may arise. evidence and declarations of GMP compliance in the API Manufacturing Process. The US FDA, however, European Regulators are now expecting the pharmaceutical products manufacturer to provide, have always insisted that GMP applies to API Manufacturing in that they have routinely inspected and approved API Manufacturing sites involved in supplying to the US market
Contact: Judith Black / Leigh White
Telephone: +44 1483 730071; Fax: +44 1483 730008
Email: info@management-forum.co.uk, leighwhite@ntlworld.com
Website: http://www.management-forum.co.uk/html/con_semin_section/con_display_event.asp?event=823
15th May 2008 at the Online in Online, USA [2108]
Update on the Pilot Process for Biomarker Qualification at the FDA and EMEA
The FDA and the EMEA are testing a Pilot Process for Biomarker Qualification, which was created based on the specific need for new biomarkers in drug development. This Pilot Process needs to be tested and refined with multiple qualification proposals.
Several representatives will be on hand to answer your specific questions and requests for clarification about biomarker qualifications. To help us to properly prepare for this question and answer period, we request that registrants submit their questions in advance to Biomarkerwebinarquestions@diahome.org.
Registrants will also have the opportunity to submit questions during the webinar through an anonymous computerized Q&A function.
Contact: Marketing Manager
Telephone: +1.215.442.6100; Fax: +1.215.442.6199
Email: dia@diahome.org
Website: http://www.diahome.org
15th May 2008 - 16th May 2008 at the Harrington Hall Hotel in London, United Kingdom [2014]
TRAIN THE PHARMACEUTICAL TRAINER - An Interactive Course
This intensive course will enable you to understand how to train others effactively through practical examples. Using a proven and best practice framework for training in the pharma industry this course will equip you with the confidence, skills, techniques and knowledge to design, deliver and implement a successful training strategy. Also available as an in-house course
Contact: Judith Black / Leigh White
Telephone: +44 1483 730071; Fax: +44 1483 730008
Email: info@management-forum.co.uk, leighwhite@ntlworld.com
Website: http://www.management-forum.co.uk/html/con_semin_section/con_display_event.asp?event=830
15th May 2008 - 16th May 2008 at the Hotel to be Advised in London, UK [1889]
PHARMACEUTICAL REGULATORY AFFAIRS IN AFRICA - Including South Africa
This meeting will be held in London. Dates in May to be confirmed
Contact: Judith Black / Leigh White
Telephone: +44 1483 730071; Fax: +44 1483 730008
Email: info@management-forum.co.uk; leighwhite@ntlworld.com
Website: http://www.management-forum.co.uk/html/con_semin_section/con_display_event.asp?event=682
16th May 2008 at the The Cavendish Hotel in London, United Kingdom [2015]
VARIATIONS TO MARKETING AUTHORISATIONS
An introduction to the EC system for variations with practical advice on the preparation and submission of variation applications using the various European procedures. Including: Regulations of the European Commission and procedures in practice; pharmaceutical variations; Clinical Variations
Contact: Judith Black / Leigh White
Telephone: +44 1483 730071; Fax: +44 1483 730008
Email: info@management-forum.co.uk, leighwhite@ntlworld.com
Website: http://www.management-forum.co.uk/html/con_semin_section/con_display_event.asp?event=836
16th May 2008 at the The Rembrandt Hotel in London, United Kingdom [1981]
PATENT PRACTICE IN CHINA - Special fee reduction for delegates attending this seminar AND Patent Practice in India on May 15 (H5-3108
This seminar will provide delegates with overall information about Chinese patent practice, while especially pointing out the important features characteristic to Chinese patent law and practice as compared with European and US patent practices. The programme examines routes of application, patentability, claim drafting, infringement, enforcement and litigation, and will also examine recent developments and changes in Chinese patent law and practice.
Contact: Judith Black / Leigh White
Telephone: +44 1483 730071; Fax: +44 1483 730008
Email: info@management-forum.co.uk, leighwhite@ntlworld.com
Website: http://www.management-forum.co.uk/html/con_semin_section/con_display_event.asp?event=371
16th May 2008 at the The Rembrandt Hotel
in London, United Kingdom [1890]
PHARMACOVIGILANCE FOR SUPPORT STAFF
This course aimes to provide an overview of the pharmacovigilance process for support staff who work directly or indirectly in this area. This invaluable course will provide a step by step overview of the processess involved, and will discuss the roles and responsibilities involved as well as explaining key terminology.
Contact: Judith Black/Leigh White
Telephone: +44 1483 730071; Fax: +44 1483 730008
Email: info@management-forum.co.uk; leighwhite@ntlworld.com
Website: http://www.management-forum.co.uk/html/con_semin_section/con_display_event.asp?event=768
18th May 2008 - 22nd May 2008 at the Madingley Hall in Cambridge, United Kingdon [1903]
Pharmacokinetic - Pharmacodynamic Data Analysis
This advanced workshop provides an interface between the computer analysis of PK and PD data and physiological concepts. Based on the background and concepts provided by the course lecturers, delegates will apply this information to the WinNonlin modeling package. A unique feature of the course is the access to the computer package to undertake hands-on exercises on real-life case studies and availability of course tutors to help in problem solving. The partici¬pants will be exposed to a wide range of preclinical and clinical pk/pd datasets based on single/multiple subjects.
Contact: Gabriella Highfield
Telephone: 02075722640; Fax: 02075722506
Email: science@rpsgb.org
Website: http://www.rpsgb.org/pdfs/scires0805.pdf
18th May 2008 - 22nd May 2008 at the Madingley Hall in Cambridge, UK [2024]
The 10th Advanced Level Workshop on Pharmacokinetic - Pharmacodynamic Data analysis -
A Hands-on Course Using WinNonlin
Based on the background and concepts provided by the course lecturers, delegates will apply this information during hands-on sessions. A unique feature of the course is the access to the computer package to undertake hands-on exercises on real-life case studies and availability of course tutors to help in problem solving.
The courses will be led by Dr Johan Gabrielsson, Senior Principal Scientist at AstraZeneca R&D Mölndal, and Dr Dan Weiner, Senior Vice President at Pharsight Corp, who are co-authors of the popular book "Pharmacokinetic and Pharmacodynamic Data Analysis: Concepts and Applications", 4th ed. (2006). Dr Gabrielsson and Dr Weiner have conducted numerous workshops on PK/PD data analysis.
Contact: Julie Churchill, Science Programme Manager
Telephone: 0044 (0)20 7572 2261; Fax:
Email: science@rpsgb.org
Website:
http://www.rpsgb.org/worldofpharmacy/events
for regular updates.
18th May 2008 - 21st May 2008 at the Red Rock Casino & Resort * Las Vegas, NV in Las Vegas, NV, USA [2036]
Oligonucleotide and Peptide® Technology and Product Development
The conference is designed to provide industry updates on developments on regulatory pathways, business landscape, analytical methods and validation, and emerging technologies.
It is the only forum that covers manufacturing, formulation, delivery, process and analytical development and overall market trends for peptide- and oligonucleotide-based therapeutics and diagnostics.
IBC’s TIDES® Conference provides strategies for economical and regulatory compliant production of peptides and oligonucleotides for therapeutics, diagnostics and research and development strategies. Thirteen case studies will be offered in addition to the 28 scientific sessions which include over 100 presentations. Attendees will have the option to pre-arrange onsite meetings with the new partnering system debuting this year.
Contact: IBC Customer Service
Telephone: (800) 390-4078; Fax: (941) 365-0104
Email: reg@ibcusa.com
Website: http://www.IBCLifeSciences.com/TIDES
19th May 2008 - 20th May 2008 at the DIA in Horsham, PA, USA [2032]
European Regulatory Affairs
This course is designed to present a comprehensive overview of the evolution of the registration systems available for approval of products in the European Union (EU) since 1995. It reviews Centralized, Mutual Recognition, and national registration procedures in detail, and includes practical examples of product types particularly suited to each procedure.
There will also be a discussion on the new medicines legislation, which was effective November 2005, and how it changed access to centralized procedure and altered regulatory data protection.
COURSE HIGHLIGHTS
* Centralized, mutual recognition, and national registration procedures in the EU
* Official regulatory policies and other issues pertinent to successful EU regulatory strategy
* EU regulatory strategy pertinent to commercial, business, and licensing arrangements
* Trademarks and patents
* Medical devices
* Clinical trial directive
* Legal status and switching
Contact: Marketing Manager
Telephone: +1.215.442.6100; Fax: +1.215.442.6199
Email: dia@diahome.org
Website: http://www.diahome.org/
19th May 2008 - 20th May 2008 at the DIA in Horsham, PA, USA [2042]
Project Information, Communication, and Knowledge Management
The success of drug research and development depends on the application of useful knowledge to the business of developing new medicines for the marketplace. Teams of preclinical, clinical, and regulatory experts collaborate to analyze and synthesize experimental data for use in good business decisions that add value to the portfolio. This course will present need-to-know information on:
* Effective communication in today’s information age
* The role of the project manager
* Managing the flow of information between team members and stakeholders
COURSE HIGHLIGHTS
* Effective communication in today’s information age
* The role of the project manager
* Managing the flow of information between team members and stakeholders
Contact: Marketing Manager
Telephone: +1.215.442.6100; Fax: +1.215.442.6199
Email: dia@diahome.org
Website: http://www.diahome.org/DIAHOME/Education/FindEducationalOffering.aspx?productID=16151&eventType=Trai
19th May 2008 at the Capitol Hilton in Washington, DC, USA [2084]
FDA/DIA Co-sponsored Conference on The Orphan Drug Act (ODA) at 25 Years: Retrospective and Future Views
In celebration of the 25th anniversary of the Orphan Drug Act, FDA, industry and patient advocacy groups are coming together to discuss accomplishments, perspectives, globalization, and future challenges in the development of therapeutic drugs and devices for the treatment of rare diseases.
Current updates on the processes, procedures, and resources to enable the successful movement of products for rare diseases from research to approval will be discussed. This will include information on Orphan Drug Designation applications,
Humanitarian Use Device designation applications, and Orphan Products Grant applications as well as other regulatory components.
Contact: Marketing Manager
Telephone: +1.215.442.6100; Fax: +1.215.442.6199
Email: dia@diahome.org
Website: http://www.diahome.org
19th May 2008 - 21st May 2008 at the Hotel Royal Pedregal in Mexico City, MEXICO [2087]
Latin American Regulatory Conference (LARC)
This conference will offer updates on global regulatory environment and how they impact the access of medicines and future research and development in the Latin America region. In-depth interactive discussion will highlight the Latin American region on the benefits, barriers, and direction of harmonization and regulatory trends will be evaluated across the lifecycle of the product.
Contact: Marketing Manager
Telephone: +1.215.442.6100; Fax: +1.215.442.6199
Email: dia@diahome.org
Website: http://www.diahome.org
19th May 2008 at the The Rembrandt Hotel
in London, United Kingdom [2050]
THE FUTURE OF PARALLEL TRADE & ITS IMPACT ON PRICING AND DISTRIBUTION - The latest issues and developments
Parallel Trade has been a major concern to the research based industry since the late 1980's. The European Commission upholds the principle of free movement of goods. National governments maintain the right to intervene on the prices of medicines. The inevitable result is price difference and parallel trade from low-priced to high-priced countries. Manufacturers complain that trade impacts their ability to invest in new products whilst traders maintain that savings from parallel trade are vital for payers. This conference will examine the real impact of parallel trade bringing expertise from all sides of the business. The focus will be on the latest developments and will explore what the future might hold for Parallel Trade and Wholesaling
Contact: Judith Black / Leigh White
Telephone: +44 1483 730071; Fax: +44 1483 730008
Email: info@management-forum.co.uk, leighwhite@ntlworld.com
Website: http://www.management-forum.co.uk/html/con_semin_section/con_display_event.asp?event=854
20th May 2008 - 21st May 2008 at the Red Rock Casino & Resort * Las Vegas, NV in Las Vegas, NV, USA [2037]
IBC’s 4th International Nucleic Acids Technologies for Diagnostics
Co-Located with IBC’s other event, TIDES®, Nucleic Acid Diagnostics is a forum for suppliers and end-users to forge collaborations and discuss the technological, regulatory, operational and business considerations surrounding the manufacturing of IVD's. It is designed to provide information on developments in regulatory pathways, business landscape and emerging technologies. Delegates will have the opportunity to meet with those involved in development, application and validation of methods for synthesis, modification, purification and characterization of any type of oligonucleotide for IVD and therapeutic applications. Presentations on recent U.S. and international regulatory developments from FDA and industrial specialists will highlight management insights and important business trends in the IVD market. The blend of presentations at Nucleic Acids Technologies for Diagnostics deals with new technologies and scientific developments together with business and regulatory considerations.
Contact: IBC Customer Service
Telephone: (800) 390-4078; Fax: (941) 365-0104
Email: reg@ibcusa.com
Website: http://www.IBCLifeSciences.com/DIAGNOSTICS
20th May 2008 at the The Rembrandt Hotel
in London, United Kingdom [2051]
PARALLEL TRADE - POST CONFERENCE WORKSHOP - IS DIRECT TO PHARMACY THE FUTURE FOR DISTRBUTION IN THE EU
Pfizer's direct-to-pharmacy (DTP) move in the UK last year shook Europe's distribution status quo. The change has profound implications for wholesalers, their customers, government payers and other manufacturers alike. It triggered a market study by the antitrust watchdog, the Office of Fair Trading (OFT), and a spate of annoucements by other manufacturer with similar plans, both in the UK and elsewhere in Europe. This workshop will examine the background to the reforms, their motivation and objectives, how changes were implemented, the reaction they provoked, what they mean in business terms to all market players, and whether their adoption in future will be even more widespread
Contact: Judith Black / Leigh White
Telephone: +44 1483 730071; Fax: +44 1483 730008
Email: info@management-forum.co.uk, leighwhite@ntlworld.com
Website: http://www.management-forum.co.uk/html/con_semin_section/con_display_event.asp?event=855
20th May 2008 - 21st May 2008 at the The Cavendish Hotel in London, UK [2016]
THE REGULATION OF VETERINARY MEDICINAL PRODUCTS IN EUROPE
Following the enforcement of Directive 2004/28 the new regulatory framework for veterinary medicines in Europe was implemented in October 2005. This major international conference will examine the implications of the new legislation, as well as reviewing critical issues in the dealing with current requirements. Another major issue confronting both industry and regulators is the continuing integration of the new and proposed accession countries into an enlarged European Union and the impact of this major step will be reviewed in detail. This conference provides an opportunity to hear up to date assessment of the European regulatory situation concerning veterinary medicines from a distinguished faculty of speakers.
Contact: Judith Black / Leigh White
Telephone: +44 1483 730071; Fax: +44 1483 730008
Email: info@management-forum.co.uk, leighwhite@ntlworld.com
Website: http://www.management-forum.co.uk/html/con_semin_section/con_display_event.asp?event=806
21st May 2008 - 23rd May 2008 at the Hotel Royal Pedregal in Mexico City, MEXICO [2086]
Emerging Regulatory Issues in Genomic Medicine
The purpose of this meeting is to identify synergies and common issues in Genomic Medicine and to develop common approaches to address these issues. The FDA has a major effort in the area of genomics and personalized medicine. It is working with clinicians, the pharmaceutical industry, and other regulatory agencies worldwide to integrate genomic medicine into medical practice.
Contact: Marketing Manager
Telephone: +1.215.442.6100; Fax: +1.215.442.6199
Email: dia@diahome.org
Website: http://www.diahome.org
21st May 2008 - 23rd May 2008 at the EMEA in Canary Wharf, London, United Kingdom [2047]
Eudravigilance - Electronic Reporting of ICSRs in the EEA
This course will be the only training programme officially recognised by the EMEA. The EMEA will present successful candidates with a 'Certificate of Completion' based on a competency assessment at the end of the course.
The EudraVigilance training programme is open to Contract Research Organisations (CROs), Consultants and other organisations with an interest in the EudraVigilance project. However, it should be noted that the persons attending the training will only be given access the EudraVigilance training environment for a period of two months. After this period the EudraVigilance system will only be available for these organisations if they act on behalf of a Marketing Authorisation Holder (MAH) or a Sponsor of a Clinical Trial and that this is notified to the EMEA in writing and through the EudraVigilance registration process.
Contact: Senior Manager of Marketing
Telephone: +41 61 225 51 51; Fax: +41 61 225 51 52
Email: diaeurope@diaeurope.org
Website: http://www.diahome.org
21st May 2008 - 22nd May 2008 at the DIA in Horsham, PA, USA [2046]
Portfolio, Strategy and Value Management
This course provides an integrated view of how corporate strategy is delivered through the portfolio of new and lifecycle drug projects. Set in a small group setting, this highly interactive course uses a case study approach to help attendees develop real-world skills in building viable portfolio, strategy, and drug value processes.
COURSE HIGHLIGHTS
•Standard processes for portfolio, strategy, and drug value management.
•How to translate generic processes into pragmatic and viable processes.
•Organizational approaches to drug value creation.
Contact: Marketing Manager
Telephone: +1.215.442.6100; Fax: +1.215.442.6199
Email: dia@diahome.org
Website: http://www.diahome.org
22nd May 2008 at the Online in Online, USA [2085]
Site and Sponsor recruitment Responsibilities from Training at the Investigator Meeting to LPLV - Third in a Patient Recruitment Webinar Series
Learn the nuances of successful recruitment planning and execution.
Site and CRO enrollment forecasts frequently fail to match actual enrollment and are typically overly optimistic. Enrollment completion target dates based on desires rather than data, are unlikely to be met, resulting in dissatisfaction, stress, and accusation.
FEATURED TOPICS
Strategies to overcome recruitment and retention challenges,
Establishing realistic benchmarks,
How to break down the patient recruitment timeline, and
Factors most likely to impact the speed of recruitment and success of retention.
Contact: Marketing Manager
Telephone: +1.215.442.6100; Fax: +1.215.442.6199
Email: dia@diahome.org
Website: http://www.diahome.org
23rd May 2008 at the The Rembrandt Hotel in London, United Kingdom [1982]
PATENTING MEDICAL TECHNOLOGY UNDER THE EPC - Problems and Challenges
The patenting of medical technology is a complex and sometimes controversial topic, as it usually involves multi-claim categories covering diagnostic, surgical and therapeutic methods. This seminar will examine in detail how aspects of patent law relating to this significant branch of technology are covered by the existing provisions of the EPC and, through the examination of existing case law and other examples, how these provisions are interpreted and implemented in practice by the EPO
Contact: Judith Black / Leigh White
Telephone: +44 1483 730071; Fax: +44 1483 730008
Email: info@management-forum.co.uk, leighwhite@ntlworld.com
Website: http://www.management-forum.co.uk/html/con_semin_section/con_display_event.asp?event=357
29th May 2008 - 30th May 2008 at the Town Hall Funabori in Tokyo, Japan [2056]
2nd Annual Conference in Japan for ASIAN NEW DRUG DEVELOPMENT
The first conference for Asian new drug development was held in Tokyo last May. Various issues were discussed from both the Sponsors and Reviewers point of view.
In the second conference, we will focus on practical issues such as: operational procedures, GCP audits, drug supply management, and medical doctor contribution. Diverse experiences will be provided. In addition, experts will be invited from mainland China, South Korea, Singapore, Taiwan and other countries to share their experiences.
Main topics are as follows:
1) Practical issues for managing multinational clinical trials including Asian countries
2) Comparative analysis of sites/ investigators among Asian countries
3) Development strategy; Asian contribution to global development.
Contact: Marketing Manager
Telephone: +1.215.442.6100; Fax: +1.215.442.6199
Email: dia@diahome.org
Website: http://www.diahome.org/DIAHOME/Education/FindEducationalOffering.aspx?productID=16711&eventType=Meet
30th May 2008 at the The Rembrandt Hotel
in London, United Kingdom [2052]
MEDIA LAW - Third annual conference
The third annual conference on Media Law offers a practical step by step guide to the legal issues encountered in media, including: Intellectual Property, Character Merchandising, Licensing, Format Rights, User Generated Content, Content Delivery, Privacy and Libel . You will be provided with the opportunity to undertake case studies in order to consolidate learning. With the increase in high profile cases year after year, there’s never been a better time to improve your media law knowledge!
Contact: Judith Black / Leigh White
Telephone: +44 1483 730071; Fax: +44 1483 730008
Email: info@management-forum.co.uk, leighwhite@ntlworld.com
Website: http://www.management-forum.co.uk/html/con_semin_section/con_display_event.asp?event=853
2nd June 2008 - 4th June 2008 at the Hyatt Regency * Cambridge, MA in Cambridge, MA, USA [2039]
IBC’s Third Annual BioProcess International Analytical and Quality Summit
This event consists of three separate conferences entitled Analytical Method Validation, Biophysical Analysis for Bioprocessing, and Process Characterization and Control. Attendees will receive materials and are able to attend any sessions from the three events.
Contact: IBC Customer Service
Telephone: (800) 390-4078; Fax: (941) 365-0104
Email: reg@ibcusa.com
Website: http://www.IBCLifeSciences.com/BPI
2nd June 2008 - 4th June 2008 at the Hilton Resort * San Diego, CA in San Diego, CA, USA [2040]
IBC’s 5th International Single-Use Applications for Biopharmaceutical Manufacturing
IBC’s 5th International Single-Use Applications for Biopharmaceutical Manufacturing will explore and analyze the latest advancements being made in downstream processing and will provide industry assessments of the latest bioreactors on the market, including perfusion production in a fully disposable bioreactor, and evaluate probes and sensors. You will gain a full range of market knowledge, including the current and future landscape of single-use manufacturing, as well as, the skills and knowledge it takes to minimize regulatory burdens and establish strategies to meet evolving business needs.
Contact: IBC Customer Service
Telephone: (800) 390-4078; Fax: (941) 365-0104
Email: reg@ibcusa.com
Website: http://www.IBCLifeSciences.com/Singleuse
5th June 2008 - 6th June 2008 at the Le Meridien Piccadilly in London, United Kingdom [2098]
DRY POWDER INHALERS
This conference is critical to those that want to understand the market place. It will provide an up-to-date discussion on systemic delivery, on patient DPI use, their likes and dislikes how they use them, plus the effect on the clinical outcomes, be prepared to be surprised by the lessons. Furthermore, current regulatory guidance affecting DPIs and the development environment will be discussed. There is much to debate and strategies yet to be defined and accepted in a ‘Quality by Design’ environment.
Contact: Judith Black / Leigh White
Telephone: 44 1483 730071; Fax: 44 1483 730008
Email: info@management-forum.co.uk
Website: http://www.management-forum.co.uk/html/con_semin_section/con_display_event.asp?event=841
5th June 2008 - 6th June 2008 at the in Baltimore, MD, USA [2094]
Medicare Advantage: Private Fee-For-Service
The Premier Conference Providing Managed Care Plans with Proactive Compliance and Operation Strategies for Increased Oversight of Emerging Issues
Over the past year, Medicare Advantage Private Fee-for-Service plans have seen immense growth, doubling the amount of enrollees nationwide. This growth provided access to care for countless members, especially in rural areas- but the record increase has been marred by countless reports of miscommunication between sales agents and beneficiaries regarding the services provided in PFFS plans. In addition, providers are becoming increasingly frustrated over delayed claims responses and falling payment rates, and as a result are no longer participating in PFFS plans. In an effort to reduce compliance concerns and expedite reviews, CMS is increasing its oversight of PFFS and suggests that the focus for health plans in 2009 should be on taking proactive measures to address challenges through increased self-monitoring. ExL Health is proud to present a conference providing PFFS plans with insight and strategies into overcoming compliance and operational challenges. Presentations will analyze the current and future status of PFFS plans while offering tactics for improving provider relations, developing beneficiary relationships and remaining compliant within sales and marketing guidelines.
Contact: Vanessa Morgenthaler
Telephone: ; Fax:
Email: info@exlpharma.com
Website: http://www.exlpharma.com/eventDetail.php?id=115
9th June 2008 - 11th June 2008 at the The Rembrandt Hotel in London, United Kingdom [2017]
BASIC PHARMACOVIGILANCE - A repeat of this successful course
This course aims to provide basic training for those concerned with pharmacovigilance. New entrants as well as experienced operators in drug safety monitoring will benefit from the mixture of scientific knowledge and practical guidance.
Contact: Judith Black / Leigh White
Telephone: +44 1483 730071; Fax: +44 1483 730008
Email: info@management-forum.co.uk, leighwhite@ntlworld.com
Website: http://www.management-forum.co.uk/html/con_semin_section/con_display_event.asp?event=828
9th June 2008 at the The Rembrandt Hotel
in London, United Kingdom [1891]
PROACTIVE PHARMA ADMINISTRATOR - How being Proactive can Maximise your Productivity and Efficiency
The Pharma Industry Today and the Changing Role of Support Staff, Developing an even more Proactive Approach to your Work, How to portray a Confident and Assertive Communication Style, Become an even more Effective Member of the Team, Optimising Efficiency and Time Management.
Contact: Judith Black/Leigh White
Telephone: +44 1483 730071; Fax: +44 1483 730008
Email: info@management-forum.co.uk; leighwhite@ntlworld.com
Website: http://www.management-forum.co.uk/html/con_semin_section/con_display_event.asp?event=769
9th June 2008 - 10th June 2008 at the Grand Union Hotel in Ljubljana, Slovenia [2088]
European Regulatory Affairs
The workshop will provide strategic advice on how to file applications for the marketing authorisations in the European Union for staff involved in International Regulatory Affairs.
Regulatory strategy which impacts on commercial, business and licensing arrangements will be of importance to those responsible for business development.
Contact: Senior Manager of Marketing
Telephone: +41 61 225 51 51; Fax: +41 61 225 51 52
Email: diaeurope@diaeurope.org
Website: http://www.diahome.org
9th June 2008 - 11th June 2008 at the Grand Union Hotel in Ljubljana, Slovenia [2089]
Essentials of Clinical Study Management
The success of a clinical study is very much dependant on its efficient preparation and effective conduct. Study managers should be knowledgeable about required quality and regulatory standards, roles and responsibilities of team members and be able to select and oversee internal and external resources. Study managers also should be able to anticipate potential problems, offer creative solutions and develop strategies to mitigate risk.
This training course provides a comprehensive overview of the essential elements of study management and the clinical study environment in the context of the overall drug development process.
After successful completion of the training course the participants will be able to efficiently plan, execute and manage a clinical study from protocol to final report.
Contact: Senior Manager of Marketing
Telephone: +41 61 225 51 51; Fax: +41 61 225 51 52
Email: diaeurope@diaeurope.org
Website: http://www.diahome.org
10th June 2008 at the EMEA in Canary Wharf, London, United Kingdom [2090]
EudraVigilance: Medicinal Product Dictionary
The EMEA has prepared this special EudraVigilance Medicinal Product Dictionary (EVMPD) course in the light of the implementation of the EU Directive on Clinical Trials (Directive 2001/20/EC).
This EVMPD course is addressing specifically all aspects related to the regulatory background, the definitions and procedures and the technical specifications for the handling and maintenance of IMP data and authorised medicinal product data in the EVMPD by the Sponsor or the MAH.
Participants will receive a training certificate that will allow them to register with EudraVigilance and to enter and maintain IMP and authorized medicinal product data in the EVMPD.
Contact: Senior Manager of Marketing
Telephone: +41 61 225 51 51; Fax: +41 61 225 51 52
Email: diaeurope@diaeurope.org
Website: http://www.diahome.org
11th June 2008 - 13th June 2008 at the EMEA in Canary Wharf, London, United Kingdom [2091]
Eudravigilance - Electronic Reporting of ICSRs in the EEA
This course will be the only training programme officially recognised by the EMEA. The EMEA will present successful candidates with a 'Certificate of Completion' based on a competency assessment at the end of the course.
The EudraVigilance training programme is open to Contract Research Organisations (CROs), Consultants and other organisations with an interest in the EudraVigilance project. However, it should be noted that the persons attending the training will only be given access the EudraVigilance training environment for a period of two months. After this period the EudraVigilance system will only be available for these organisations if they act on behalf of a Marketing Authorisation Holder (MAH) or a Sponsor of a Clinical Trial and that this is notified to the EMEA in writing and through the EudraVigilance registration process.
Contact: Senior Manager of Marketing
Telephone: +41 61 225 51 51; Fax: +41 61 225 51 52
Email: diaeurope@diaeurope.org
Website: http://www.diahome.org
12th June 2008 - 13th June 2008 at the The Rembrandt Hotel in London, United Kingdom [2018]
PATENT SYSTEMS IN EUROPE - A Schematic Overview
This course aims to provide a unique schematic overview of the multinational aspects of the Patent System in Europe, with selected topics being discussed in depth A brief outline of the various patent-related international treaties in force will be followed by a more detailed examination of both the European Patent Convention (EPC) and the Patent Cooperation Treaty (PCT). The interface between the two systems will be explained. The changes to the EPC and the PCT Rules will also be outlined.
Contact: Judith Black / Leigh White
Telephone: +44 1483 730071; Fax: +44 1483 730008
Email: info@management-forum.co.uk, leighwhite@ntlworld.com
Website: http://www.management-forum.co.uk/html/con_semin_section/con_display_event.asp?event=825
12th June 2008 at the King’s College London –Waterloo campus in London, United Kingdon [1961]
COMBATING COUNTERFEIT MEDICINES
Counterfeit medicines are estimated as more than 10% of the global medicines market and in some developing countries it is thought to be as high as 50%. One prediction is that global counterfeit drug sales will reach US$ 75 billion by 2010.
This symposium looks at methods to detect counterfeit medicines, the current and prospective legislative position, and ways to combat counterfeiting. The exhibition presents relevant equipment and systems to detect and combat counterfeit medicines.
Contact: Gabriella Highfield
Telephone: 02075722640; Fax: 02075722506
Email: science@rpsgb.org
Website: http://www.jpag.org/
12th June 2008 - 17th June 2008 at the Shanghai Everbright Convention & Exhibition Center in Shanghai, China [1898]
World Cancer Congress-2008
More than 600 cancer specialists from a wide range of disciplines will participate in the scientific program and their presentations will provide delegates with information on the latest developments in basic and clinical research. The conference has broad public support and has the additional goal of spreading and increasing the understanding of modern biological sciences among the lay public.
Contact: Annie Sun
Telephone: 0086-411-84799479; Fax: 0086-411-84799629
Email: annie@bitlifesciences.com
Website: http://www.bitlifesciences.com/cancer2008/
12th June 2008 at the Hardwicke Building, Lincolns Inn in London, United Kingdom [2099]
W H O is TURNING THE LIGHTS OUT ON DRUG DEVELOPMENT? - The Crisis facing The Pharmaceutical Industry
This conference will examine the potential effect on the pharmaceutical industry of negoitations currently under way at the World Health Organisation which could see a fundamental change to the global IP rules which currently underpin R&D. The conference will survey the political and economic context behind the WHO negotiations, and offer perspectives into the likely impact on innovation and health of the reforms under discussion. It will also provide a valuable forum for discussion of these complex issues.
Contact: Judith Black / Leigh White
Telephone: 44 1483 730071; Fax: 44 1483 730008
Email: info@management-forum.co.uk
Website: http://www.management-forum.co.uk/html/con_semin_section/con_display_event.asp?event=873
12th June 2008 - 13th June 2008 at the Radisson SAS Hotel in Nice, France [1935]
THE EU PHARMACEUTICAL DOSSIER
Full details to follow. Please contact for a brochure: info@management-forum.co.uk
Contact: Judith Black / Leigh White
Telephone: +44 1483 730071; Fax: +44 1483 730008
Email: info@management-forum.co.uk, leighwhite@ntlworld.com
Website: http://www.management-forum.co.uk/html/con_semin_section/con_display_event.asp?event=699
15th June 2008 - 19th June 2008 at the Melia Sitges Hotel in Sitges, Spain [1946]
Ninth Eilat Conference on New Antiepileptic Drugs (EILATIX)
The conference program is designed to provide an in-depth progress report on new antiepileptic drugs in different stages of development, as well as to present new findings on second-generation treatments. In addition, sessions will be devoted to:
•Old and New AEDs in Generalized Epilepsies
•Novel Formulations and Routes of Administration of AEDs
•Common Targets and Mechanism of Action for Drugs for the Treatment of Epilepsy and other CNS disorders
•Perspectives on AED discovery
Contact: Karyn Nahari, Target Conferences Ltd.
Telephone: +972 3 517 5150; Fax: +972 3 517 5155
Email: eilatix@targetconf.com
Website: http://www.eilat-aeds.com/ix/index.asp
16th June 2008 - 20th June 2008 at the The Rembrandt Hotel in London, United Kingdom [2019]
THE ANIMAL HEALTH SUMMER SCHOOL
Full details to follow. Please contact for a brochure: info@management-forum.co.uk
Contact: Judith Black / Leigh White
Telephone: +44 1483 730071; Fax: +44 1483 730008
Email: info@management-forum.co.uk, leighwhite@ntlworld.com
Website: http://www.management-forum.co.uk/html/con_semin_section/con_display_event.asp?event=838
16th June 2008 - 18th June 2008 at the Venue: Radisson Hotel in Boston, Mass, USA [2072]
PHARMACEUTICAL REGULATORY AFFAIRS IN LATIN AMERICA
This seminar will provide up-to-date coverage of the requirements that underpin a successful marketing authorisation application for pharmaceutical products across Latin America. In a carefully structured programme, speakers will cover the official regulatory sources but will also share the interpretation and alternatives to local/specific legal requirements that only people with hands-on experience in the region can provide. This seminar will also include an overview of the regulatory aspects of site inspection for Brazil, Mexico and Colombia and the requirements for the marketing of NCE Biological Products, Generic drugs and OTC medicines. Interactive workshops have been incorporated into the programme where participants will be invited to put learning into practice through the resolution of case studies. It is anticipated that the seminar will be useful both as an introductory course and as a refresher course to people who need to have an up-to-date and wide knowledge of the subject areas.
Contact: Judith Black / Leigh White
Telephone: +44 1483 730071; Fax: +44 1483 730008
Email: info@management-forum.co.uk, leighwhite@ntlworld.com
Website: http://www.management-forum.co.uk/html/con_semin_section/con_display_event.asp?event=852
16th June 2008 - 20th June 2008 at the The Rembrandt Hotel in London, United Kingdom [1936]
THE PATENT SUMMER SCHOOL - A comprehensive, residential course for non-lawyers
Patents are the most valuable assets of any innovative organisation. It is vital to the success and commercial well-being of a company that it understands the principles, procedures and practices involved in obtaining, challenging, defending and exploiting their patents. This course will give a comprehensive introduction to the complex world of patents. With practical illustrations, it will outline the basic concepts of intellectual property and explain the roles and responsibilities of those directly involved. It will provide a basic understanding of the various international patent systems and major theatres of jurisdiction. It will explain the principles of litigation in the three major patent superpowers, Europe, USA and Asia, and advise on IP strategy and the management of a patent portfolio.
Contact: Judith Black / Leigh White
Telephone: +44 1483 730071; Fax: +44 1483 730008
Email: info@management-forum.co.uk, leighwhite@ntlworld.com
Website: http://www.management-forum.co.uk/html/con_semin_section/con_display_event.asp?event=449
18th June 2008 at the The Rembrandt Hotel
in London, United Kingdom [2073]
THE EU COSMETICS DIRECTIVE - All You Need To Know To Market Your Product In Europe
A quick examination of the cosmetic products sold in many European shops will pick up a significant number of products that do not comply with the EU Cosmetic Regulations. This demonstrates that there are many companies who do not understand the requirements. The EU has recently stated that they wish to enforce labelling requirements more vigorously and there are heaving fines for infringements. It is easy for the authorities to walk round any shop selling cosmetics and look at the labels. Even a minor infringement could lead to a time-consuming investigation. Although very complex and lengthy, the regulations are actually quite straightforward if they are summarised, explained properly and put into context. The object of this symposium is to just this in thorough and simple terms. You will learn what the EU Cosmetics Driective is, how to understand and comply with it.
Contact: Judith Black / Leigh White
Telephone: +44 1483 730071; Fax: +44 1483 730008
Email: info@management-forum.co.uk, leighwhite@ntlworld.com
Website: http://www.management-forum.co.uk/html/con_semin_section/con_display_event.asp?event=862
19th June 2008 at the Online in Online, USA [2096]
Creating a Value Proposition for the Potential Participant and Their Family - Fourth in a Patient Recruitment Webinar Series
Learn the nuances of successful recruitment planning and execution.
Building awareness of a new study with potential participants has become more complex. Market research data has shown that many patients will not consider study participation unless the study is endorsed by their family doctor and supported by their family caregiver. Creating documents that patients will read, understand, and share before participating in a trial is important because it is one of the first opportunities the sponsor has to explain the purpose of the trial and convey what they are expected to do and what they will receive in return. Few sponsors or CROs prepare adequate patient education materials for these enfranchised members.
Contact: Marketing Manager
Telephone: +1.215.442.6100; Fax: +1.215.442.6199
Email: dia@diahome.org
Website: http://www.diahome.org
20th June 2008 - 22nd June 2008 at the Hyatt Regency Reston in the Reston Town Center in Reston, VA 20190, USA [1958]
The APNA 6th Annual Psychopharmacology Institute Conference
This conference will cover psychopharmacology across the lifespan of an individual. The sessions and sponsored symposia will discuss a lot of topics that affect people of all ages with attention paid to specific Child & Adolescent, College-Age and Gero-Psych issues.
Contact: Mahnaaz Wolf
Manager, Marketing & Membership
APNA
Telephone: 703-387-7102; Fax:
Email: mwolf@apna.org
Website: http://www.apna.org/
22nd June 2008 - 25th June 2008 at the Cardiff University in Cardiff, Wales, UK [1945]
Second Cellular Delivery of Therapeutic Macromolecules Symposium.
The main focus of the meeting is to develop the interest and knowledge of Early Stage Career Researchers in issues surrounding strategies by which potential therapeutic Macromolecules overcome biological barriers to gain access to cells and subcellular organelles.
Registration costs are therefore very low to encourage delegates to attend and learn about this important field of research.
The symposium boasts a very impressive list of International speakers covering:
Endocytosis and organisation of the plasma membrane
Interaction of Polyplexes with cellular barriers
Challenges of Gene delivery for Cancer therapeutics
Gene Delivery Vector components
Cell penetrating peptides
siRNA
Antibody transport across biological barriers
Exploiting transcytosis for macromolecular drug delivery
Macromolecule Transport through the Blood Brain Barrier
Macromolecule Transport through Epithelial barriers
Polymer interactions with cells
Contact: Dr Arwyn Jones
Telephone: +44 (0)2920876431; Fax: +44 (0)2920874536
Email: CDTM2008@cardiff.ac.uk
Website: http://www.cdtm2008.cardiff.ac.uk/
22nd June 2008 - 26th June 2008 at the Boston Convention and Exhibition Center in Boston, MA, USA [1661]
44th DIA Annual Meeting
The DIA Annual Meeting is the "event to attend" each year for biotechnology, pharmaceutical, and regulatory professionals. No other industry meeting of its kind can rival the breadth and depth of experience that this meeting delivers, with 28 content-area tracks and 300 sessions, and presentations geared to attendees of all experience levels. The DIA Annual Meeting, above all others, offers valuable professional cross-functional learning, networking experiences, and continuing education credits for attending tutorials and sessions.
Contact: Marketing Manager
Telephone: +1.215.442.6100; Fax: +1.215.442.6199
Email: dia@diahome.org
Website: http://www.diahome.org/DIAHome/Education/FindEducationalOffering.aspx?productID=14235&eventType=Annu
23rd June 2008 - 24th June 2008 at the The Rembrandt Hotel
in London, [2053]
TECHNOLOGY LICENSING - Fundamentals and Strategy for Maximizing Value of Intellectual Capital
Obtaining intellectual property rights or maintaining trade secret protection for technology is only the beginning. To take full commercial advantage of this protection one must be aware of the opportunities offered by successful licensing of the technology. This course will outline the principles of international technology licensing, and examine the important stages of a successful license arrangement, starting with making the decision to license and determining how best to maximize value, through to negotiating and finalising a targeted and robust license in an international marketplace. The course will also look at what happens after the agreement has been signed. The course is technology non-specific, but unique aspects of high-tech and biotech licensing will be addressed.
Contact: Judith Black / Leigh White
Telephone: +44 1483 730071; Fax: +44 1483 730008
Email: info@management-forum.co.uk, leighwhite@ntlworld.com
Website: http://www.management-forum.co.uk/html/con_semin_section/con_display_event.asp?event=856
23rd June 2008 at the The Rembrandt Hotel
in London, United Kingdom [2074]
ESSENTIAL GUIDE TO PHARMACOVIGILANCE - A one day concise overview
Pharmacovigilance has become one of the most demanding aspects for licence holders to both understand and comply with. There are many requirements for Companies to perform various duties regarding the safety of their products to satisfy regulatory demands. Regulatory Authorities are visiting all licence holders to perform inspections on a Company's compliance to Pharmacovigilance and the visits can also include visiting marketing partners as well (even outside the EU) and the sanctions that exist for those Companies who do not look after the safety of their products are severe and could result in licence withdrawal. This course has been designed to simply explain what Companies need to be aware of in terms of their responsibilities and what they need to do to avoid regulatory action. Can you afford not to know?
Contact: Judith Black / Leigh White
Telephone: +44 1483 730071; Fax: +44 1483 730008
Email: info@management-forum.co.uk, leighwhite@ntlworld.com
Website: http://www.management-forum.co.uk/html/con_semin_section/con_display_event.asp?event=861
23rd June 2008 - 25th June 2008 at the Hilton Resort * San Diego, CA in San Diego, CA, USA [2038]
IBC’s 4th Annual Cell Line Development and Engineering
IBC’s Cell Line Development and Engineering event has quickly evolved into the most comprehensive industry forum that covers every critical stage of development from late discovery through production. Working together with world renowned academics and industry leaders, this event delivers proven methods and strategies to shorten timelines and workflows and find the right balance between speed and quality, techniques and tools (i.e. high-throughput screening) to enhance cell line productivity and improve manufacturability, increasing product quality through approaches to improve predictability and stability, applying genomic, proteomic and metabolomic approaches to enhancing host cell properties during cell line development, as well as disruptive innovations and alternative expression systems that will change how proteins are produced.
Contact: IBC Customer Service
Telephone: (800) 390-4078; Fax: (941) 365-0104
Email: reg@ibcusa.com
Website: http://www.IBCLifeSciences.com/CellLine
24th June 2008 at the The Rembrandt Hotel
in London, United Kingdom [2075]
E2B REPORTING - Do you comply with Regulatory Requirements?
Electronic reporting via ICH E2B in the EU has been mandatory since 20th November 2005. Although, long past this deadline it has taken time for individual Regulatory Agencies to become live with these systems. Now the Agencies are ready and industry is expected to comply and provide all cases both post marketing ICSRs and clinical SUSARs electronically and have contingencies for any system failures. This course is intended to explain to people the multiple ways of reporting, individual variation in submissions by country, the monitoring of compliance and the registration process and oversight of the EU QP PV.
Contact: Judith Black / Leigh White
Telephone: +44 1483 730071; Fax: +44 1483 730008
Email: info@management-forum.co.uk, leighwhite@ntlworld.com
Website: http://www.management-forum.co.uk/html/con_semin_section/con_display_event.asp?event=786
25th June 2008 at the The Rembrandt Hotel
in London, United Kingdom [2054]
VETERINARY PHARMACOVIGILANCE VOLUME IXB
Volume IXb is the new key document on Pharmacovigilance guidelines used by the Veterinary regulatory authorities. The purpose of this course is to examine the new aspects and impacts of Volume IXb in readiness for Pharmacovigilance Inspections, compliance, safety reporting and the roles and responsibilities of the Company and European Qualified Person for Pharmacovigilance in terms of safety assessments in the European Union. The new Volume IXb provides greater clarity to old issues, as well as detailing a number of new aspects for the Pharmacovigilance Professional to contend with. There are many new areas to be discussed in Volume IXb and this seminar will provide an excellent opportunity to understand the implications of the changes.
Contact: Judith Black / Leigh White
Telephone: +44 1483 730071; Fax: +44 1483 730008
Email: info@management-forum.co.uk, leighwhite@ntlworld.com
Website: http://www.management-forum.co.uk/html/con_semin_section/con_display_event.asp?event=839
27th June 2008 at the EMEA in Canary Wharf, London, United Kingdom [2097]
4th EudraVigilance Information Day
The electronic transmission of ICSRs is a key element in improving the process of adverse reaction reporting in pharmacovigilance. It is not only a major step forward in providing information more rapidly but also in standardizing the way clinical safety data elements are presented, thereby improving the collective ability to evaluate complex data.
This programme will address the latest status in the EEA regarding the electronic reporting initiatives from Regulator and Industry perspectives. The special areas that will be covered in depth are:
Panel discussions will provide the opportunity for extensive Q&As with the experts.
Contact: Senior Manager of Marketing
Telephone: +41 61 225 51 51; Fax: +41 61 225 51 52
Email: talana.bertschi@diaeurope.org
Website: http://www.diahome.org
30th June 2008 - 1st July 2008 at the The Rembrandt Hotel
in London, United Kingdom [2076]
PHARMACEUTICAL REGULATORY AFFAIRS IN CHINA
This seminar will provide an up-to-date coverage of all aspects playing an important role in gaining and maintaining a successful marketing authorisation for R&D based pharmaceutical products in PR China. In this carefully balanced programme, speakers will cover the underlying official regulatory sources and share the interpretation and practical aspects of putting these into practice in a day-to-day scenario. This seminar will also include an overview of the requirements for local manufacturing as well as of the patent situation and the current legal framework for pharmaceutical patents in PR China. An interactive session has been incorporated into the programme where participants will be invited to put learning into practice through the resolution of case study. It is anticipated that this seminar will be useful both as an introductory course and as a refresher course to people who need to have an up-to-date and wide knowledge of the subject area.
Contact: Judith Black / Leigh White
Telephone: +44 1483 730071; Fax: +44 1483 730008
Email: info@management-forum.co.uk, leighwhite@ntlworld.com
Website: http://www.management-forum.co.uk/html/con_semin_section/con_display_event.asp?event=851
30th June 2008 - 4th July 2008 at the The Rembrandt Hotel
in London, United Kingdom [2077]
MEDICAL DEVICE SUMMER SCHOOL - From Concept to CE Marking
Bringing a Medical Device to the market place is a complex and lengthy procedure which requires experience, knowledge and specialist skills. The contribution to successful market placement comes from many different skilled individuals and organisations. Those contributing towards the placing of devices on the market should be aware of all of the stages involved and be able to relate their responsibilities to the needs of other professionals, scientists, clinicians and regulatory and quality experts. This comprehensive course has been designed to map the processes from device concept to marketing and show how regulatory, quality, clinical and other aspects of device development are joined into a continuous process. It will commence with a general introduction and to what devices are, how they are developed and continue with lectures, workshops and case studies covering each process applicable to device development, marketing and eventually the post market procedures. There will be ample time for informal discussions alongside the presentations and workshops.
Contact: Judith Black / Leigh White
Telephone: +44 1483 730071; Fax: +44 1483 730008
Email: info@management-forum.co.uk, leighwhite@ntlworld.com
Website: http://www.management-forum.co.uk/html/con_semin_section/con_display_event.asp?event=843
1st July 2008 - 2nd July 2008 at the The Rembrandt Hotel in London, United Kingdom [2100]
EUROPEAN MARKETING CODES AND COMPLIANCE - A Two Day Essential Overview
A mixture of regulation and self-regulation governs the promotion of pharmaceuticals worldwide and the balance between the two differs from country to country. The detailed rules regarding promotional practices is often contained within the national self-regulatory codes of conduct of the pharmaceutical industry associations, which also vary across the world. This makes global, international or pan European marketing of medicines extremely complex. This two-day seminar, has been designed to increase the knowledge and understanding of the rules governing the promotion of medicines in these different markets, with a particular focus on Europe. It will contain highly interactive workshops, with practical exercises aimed at equipping participants to meet business objectives of global or pan European marketing by raising awareness of local variability in compliance requirements. PCMPA, Marketing, Codes, EFPIA, Promotional,
Contact: Judith Black / Leigh White
Telephone: 44 1483 730071; Fax: 44 1483 730008
Email: info@management-forum.co.uk
Website: http://www.management-forum.co.uk/html/con_semin_section/con_display_event.asp?event=877
2nd July 2008 at the The Rembrandt Hotel
in London, United Kingdom [1892]
THE CTD: AN INTRODUCTORY OVERVIEW FOR SUPPORT STAFF
An overview on the structure and format of the ICH Common Technical Document Its implementation in Europe, Switzerland, the US, Canada, Japan and Australia, and how to file an electronic CTD (eCTD).
Contact: Judith Black/Leigh White
Telephone: +44 1483 730071; Fax: +44 1483 730008
Email: info@management-forum.co.uk,leighwhite@ntlworld.com
Website: http://www.management-forum.co.uk/html/con_semin_section/con_display_event.asp?event=770
3rd July 2008 at the The Rembrandt Hotel in London, United Kingdom [2101]
USER TESTING OF PILS - User Testing – Tackling the New Regulations for Writing Effect PILs
Why do we need readability testing? Are you confident your PIL will receive regulatory approval? It is now mandatory to test all patient information leaflets through “consultations with target patient groups” to comply with EU Pharma regulations. The aim is to improve the effectiveness of Patient Information Leaflets and make them more user-friendly. The UK approach to this process is firmly through the application of User Testing and this seminar will feature a presentation from the MHRA and contributions from 2 researchers from the University of Leeds with extensive expertise in consumer medicines information and of conducting readability testing of PILs. The seminar aims to describe what User Testing means and how it can be tackled by the pharmaceutical industry?
Contact: Judith Black / Leigh White
Telephone: 44 1483 730071; Fax: 44 1483 730008
Email: info@management-forum.co.uk
Website: http://www.management-forum.co.uk/html/con_semin_section/con_display_event.asp?event=651
7th July 2008 - 8th July 2008 at the The Rembrandt Hotel in London, United Kingdom [2020]
EU PHARMACEUTICAL REGULATIONS
Regulatory Affairs has an acknowledged important role in the Pharmaceutical Industry, both in obtaining and maintaining marketing authorisations. Therefore, knowledge of the current European requirements and the impact of legislative changes on the businesses are essential. This two-day seminar provides an up-to-date overview of current EU regulatory requirements and procedures relating to human pharmaceuticals, through interactive presentations. In addition, it includes two workshops designed to look at the practical implementation and to consolidate the information presented during this two-day seminar.
Contact: Judith Black / Leigh White
Telephone: +44 1483 730071; Fax: +44 1483 730008
Email: info@management-forum.co.uk, leighwhite@ntlworld.com
Website: http://www.management-forum.co.uk/html/con_semin_section/con_display_event.asp?event=827
8th July 2008 - 11th July 2008 at the Copthorne Hotel & Resort in Queenstown, South Island, New Zealand [1969]
15th International Social Pharmacy Workshop, 2008
'Globalisation, Pharmacy and Medicines'
The School of Health & Social Care, Bournemouth University, UK and The School of Pharmacy, University of Auckland, NZ are delighted to be hosting the 15th International Social Pharmacy Workshop at the Copthorne Hotel & Resort in Queenstown, New Zealand from Tuesday 8 July to Friday 11 July, 2008. We sincerely hope that you will be able to join us and your colleagues for four days of education, enlightenment, entertainment, networking and convivial good fun!
The theme for the workshop is "Globalisation, Pharmacy and Medicines” and the aim is to explore everything from education and workforce issues to counterfeit drugs and internet sales. We especially invite critical perspectives and commentary.
More information can be found on the website below.
Contact: Nikky Church
Telephone: +64-9-3737599 extension 86260 or 87738; Fax: +64-9-3677195
Email: n.church@auckland.ac.nz
Website: http://www.bournemouth.ac.uk/hsc/ispw.html
9th July 2008 at the Harrington Hall Hotel in London, United Kingdom [2102]
LABELLING AND INSTRUCTIONS FOR USE FOR MEDICAL DEVICES AND IVDS
This seminar will look at the current regulatory environment and future developments for labelling of Medical Devices and In-Vitro Diagnostics (IVDs). It will provide guidance on labelling standards and the use of symbols. The important issues surrounding IFUs will be discussed and advice will be given on how to provide ‘Instructions for Use’ to users. A comprehensive overview of the National language requirements will be discussed and advice provided on what to consider when establishing a translation process.
Contact: Judith Black / Leigh White
Telephone: 44 1483 730071; Fax: 44 1483 730008
Email: info@management-forum.co.uk
Website: http://www.management-forum.co.uk/html/con_semin_section/con_display_event.asp?event=840
9th July 2008 - 11th July 2008 at the The Rembrandt Hotel
in London, United Kingdom [2103]
PUBLICATION STRATEGY AND PLANNING SUMMER SCHOOL - A Comprehensive 3 day Residential Course, with Interactive Workshops
Publication Strategy and Planning Good publication strategies and intelligent planning can maximize the benefits from publications, avoid missing important communications opportunities and increase the return on investment for clinical trials. On the other hand, lack of a strategy and poor planning can lead to delays and tension between investigators / opinion leaders and research sponsors and even damage the reputation of your company. Developing and delivering effective publication strategies and plans requires in-depth knowledge about how journals and conferences operate, keeping abreast of a wide range of rapidly moving guidelines and mastering a number of ‘people skills’. This course will explain the roles of publication policies, strategies and plans. Participants will learn how to convert strategies into effective plans, gain knowledge about journals and meetings and increase their understanding about the latest rules and regulations governing publications. In practical sessions, participants will be able to apply this knowledge to create realistic timetables. They will also gain valuable insights from journal editors and other publications professionals.
Contact: Judith Black / Leigh White
Telephone: 44 1483 730071; Fax: 44 1483 730008
Email: info@management-forum.co.uk
Website: http://www.management-forum.co.uk/html/con_semin_section/con_display_event.asp?event=878
10th July 2008 - 11th July 2008 at the Venue: The Rembrandt Hotel
in London, United Kingdom [2078]
US FDA APPROVAL PROCESS FOR MEDICAL DEVICES
This seminar will highlight new changes in the medical device regulations and provide an overview of the submission of documents to the FDA for approval of medical device products. Participants will gain a better understanding of the medical device approval process and the underlying scientific and regulatory principles involved. Guidelines for each aspect of research will be provided, as well as information on the structuring of submissions and post-approval documents. Information on maintaining ongoing relationships with the FDA will also be discussed. Attendance at this seminar will enable delegates to provide the FDA with the necessary information to obtain product approval. Upon completion of this seminar, participants will: Understand the FDA medical device approval system, Know what is required for an Investigational Device Exemption (IDE), Learn the contents of a Post-Market Approval (PMA) and Learn what to include in an annual report
Contact: Judith Black / Leigh White
Telephone: +44 1483 730071; Fax: +44 1483 730008
Email: info@management-forum.co.uk, leighwhite@ntlworld.com
Website: http://www.management-forum.co.uk/html/con_semin_section/con_display_event.asp?event=844
14th July 2008 - 15th July 2008 at the The Heldrich in New Brunswick, NJ, [2071]
4th Annual, Public Relations & Communications Summit
Key Themes for 2008 Agenda:
Harnessing Change Control both Internally and Externally
Enhancing Media Communication & Outreach
Embracing New Social Media Tools
Demonstrating the Value of PR within your Organization
Contact: Bryon Main
Telephone: 212-400-6240; Fax:
Email: info@exlpharma.com
Website: http://www.exlpharma.com/eventDetail.php?id=112
17th July 2008 - 18th July 2008 at the Gaylord National Resort and Convention Center
National Harbor (Washington, DC Area), MD, USA
in National Harbor, MD, USA [2110]
Next Generation Vaccines
IBC's Next Generation Vaccines will feature TWO concurrent conferences: Discovery & Development and Production & Process Development. This will allow you the opportunity to network with attendees in either of these fields AND with those who are up- or down-stream from your own. This is your opportunity to learn what your peers are doing, understand where the latest technology innovations are coming from and learn how they are being channeled down. It is the one event that will give you TWO views - an overview of the industry from the discovery and development angle as well as the process development and production perspective. This highly acclaimed event will offer the depth of topics you need to further your insights into each area.
Contact: Contact: IBC Customer Service
Telephone: (800) 390-4078; Fax: (941) 365-0104
Email: reg@ibcusa.com
Website: http://www.ibclifescience.com/Vaccines
21st July 2008 - 25th July 2008 at the The Rembrandt Hotel
in London, United Kingdom [2055]
WORKING THROUGH DRUG DEVELOPMENT - Summer School
The development of a new medicine is complex because it requires many different skills. Everyone involved must be aware of the main stages and be able to relate his or her responsibilities to the professional knowledge and needs of other scientists and clinicians. this course has been designed to show how toxicology,clinical investigations and regulatory practices are joined into a continuous process. It will commence with a general introduction to the process of drug development and continue with lectures on the following aspects: Toxicological requirements, Pharmaceutical and Analytical development, Marketing and Business Development, Pharmacokinetic and Metabolic studies, Phase I and healthy volunteer work: Phase II/III - trial design and protocols, and clinical project management; Handling Safety Data in development; ending on the final day with regulatory matters including marketing applications and post-marketing activities.
Contact: Judith Black / Leigh White
Telephone: +44 1483 730071; Fax: +44 1483 730008
Email: info@management-forum.co.uk, leighwhite@ntlworld.com
Website: http://www.management-forum.co.uk/html/con_semin_section/con_display_event.asp?event=99
27th July 2008 - 1st August 2008 at the Québec City Convention Centre in Québec City, Canada [1078]
The IXth World Conference on Clinical Pharmacology and Therapeutics, CPT2008
The purpose of CPT2008 is to congregate recognized international experts, in all areas of clinical pharmacology, to allow open discussions on the advances of drug research and utilization. To ensure an excellent and diverse program, and cover the interests of pharmacologists, and clinical pharmacologist worldwide, the Scientific Program Committee includes distinguished scientists from most areas of the world.
Contact: Marie Lanouette, Conference Manager
Telephone: 613-993-0414; Fax: 613-993-7250
Email: cpt2008@nrc-cnrc.gc.ca
Website: http://www.cpt2008.org/
28th July 2008 - 29th July 2008 at the Estancia La Jolla Hotel & Spa
in La Jolla, CA, USA [2109]
Beyond Antibodies
IBC’s third annual Beyond Antibodies conference is the industry’s only event to focus exclusively on alternatives to antibody technology. Next generation antibody and protein scaffolds are continually being developed and rapid advancements have been made in this highly emerging field. The development of these technologies is to overcome the limitations of traditional antibody technology and reduce the time of drug discovery. This year’s conference will cover the recent advancements and scientific benefits, as well as business perspectives driving much of the M & A activity.
Contact: Contact: IBC Customer Service
Telephone: (800) 390-4078; Fax: (941) 365-0104
Email: reg@ibcusa.com
Website: http://www.ibclifesciences.com/Beyond
4th August 2008 - 7th August 2008 at the World Trade Center Boston & Seaport Hotel
Boston, MA USA
in Boston, MA, USA [2111]
Drug Discovery & Development of Innovative Therapeutics
Practical, Actionable Ideas for Accelerating Discovery and Early Development
The Drug Discovery & Development of Innovative Therapeutics (DDT) World Congress is the ONLY international event that compares applications of translational medicine and transforming technologies across multiple therapeutic areas to help you find new ways to achieve POC quickly. Over 200 speakers will provide new ideas, creative technologies and scientific strategies covering the following topic areas: Therapeutic Advances in: Cancer, Cardio-Metabolic, Neurodegeneration, Anti-infectives, Orphan Diseases, Inflammation; Transforming Technologies; Translational Medicine; and R&D Strategies.
Contact: Contact: IBC Customer Service
Telephone: (800) 390-4078; Fax: (941) 365-0104
Email: reg@ibcusa.com
Website: http://www.drugdisc.com
4th August 2008 - 5th August 2008 at the DIA in Horsham, PA, USA [2138]
Resource Management at the Functional and Enterprise Levels
Learn how to build, implement, and maintain a Resource Management business system, as well as accommodate the reverberations of the cultural change and how to get buy-in from all the key stakeholders.
COURSE HIGHLIGHTS
•The Resource Management Business System
•Linking the Resource Management System with Portfolio, Functional and Project Management Systems
•Building and Implementing a Resource Management System
•Sustaining a Resource Management System after Implementation
•Roles and Responsibilities
•Handling Cultural Changes.
Contact: Marketing Manager
Telephone: +1.215.442.6100; Fax: +1.215.442.6199
Email: dia@diahome.org
Website: http://www.diahome.org
4th August 2008 - 8th August 2008 at the Massachusetts College of Pharmacy in Boston, MA, USA [2118]
Regulatory Affairs: Part I: The IND Phase, Part II: The CTD/NDA Phase
This course combines the two three-day courses into one extended five-day offering. It describes the regulatory background of the IND and NDA and provides an overview of the requirements and recommendations for preparing and managing these applications.
Please note that this August offering is a 5 day version of Regulatory Affairs: Part I: The IND Phase and Part II: The CTD/NDA Phase.
Contact: Marketing Manager
Telephone: +1.215.442.6100; Fax: +1.215.442.6199
Email: dia@diahome.org
Website: http://www.diahome.org
11th August 2008 - 12th August 2008 at the Hyatt Regency Bethesda in Bethesda, MD, USA [2139]
Overview of Drug Development in Japan
The Japanese pharmaceutical market, with sales of $60 billion in 2005, is the second largest market comprising approximately 11% of the global market. Despite the size of this market, many multinational companies struggle to synchronize or integrate
Drug development in Japan with the US/EU. As a result, there continues to be a significant lag in new drug approvals in Japan as compared to the West.
There are many barriers to successful drug development in Japan and this course has been specifically designed to provide some insight into this process. Through a series of highly interactive presentations and case studies, this course will explore the
Developmental requirements, regulatory environment, and commercial opportunities for medicines in Japan.
Contact: Marketing Manager
Telephone: +1.215.442.6100; Fax: +1.215.442.6199
Email: dia@diahome.org
Website: http://www.diahome.org
1st September 2008 - 7th November 2008 at the Department of Pharmacology, University of Gothenburg in Gothenburg, Sweden [2059]
IQP - Integrated Quantitative Pharmacology:
Concepts and Applications
There is a tremendous demand for PK and PK/PD trained analysts within Academia, Industry and Regulatory Agencies as well as for researchers and analysts with in-depth knowledge in Integrated Pharmacology. There is also a costly time-lag from the Industry’s need of this competence and request for new courses, to the final output of competent scientists. The gap between need and what is provided by educational institutions is continuously growing. Since there are very little formal academic training programs on the Master level within Europe in this field, this advanced course is aimed to bridge some of that gap. The programme is aimed to give the participant a sense that when he/she is entering the scientific area, this is knowledge that has immediate bearings on the drug discovery-development process. The course provides an interface between the computer analysis of PK and PD data and physiological concepts. Based on the background and concepts provided by the course lecturers, delegates will apply this information to the WinNonlin industry standard modeling package. A unique feature of the course is the access to the computer package to undertake hands-on exercises on real-life case studies and availability of course tutors to help in problem solving. The participants will be exposed to a wide range of real life preclinical and clinical PK/PD datasets based on single/multiple subjects. There will be a 2-day introductory PK/PD module starting at the beginning of the main programme.
Contact: Patrik Aronsson
Telephone: + 46 - 31 - 786 3440; Fax: + 46 - 31 - 82 10 85
Email: patrik.aronsson@pharm.gu.se
Website: http://www.pharmguse.net/advanced/advanced-courses.html
2nd September 2008 - 5th September 2008 at the Venue: The Cavendish Hotel
in London, United Kingdom [2104]
EU DRUGS REGULATION FROM DISCOVERY TO MARKETING AND BEYOND
The conference has been designed as an interesting blend of regulatory, chemical, biological and clinical science to be suitable for delegates wanting to gain a broad multi-disciplinary understanding of how to get a suitable candidate drug substance approved for clinical trials and for later sale and supply as a licensed medicine (drug product) in the European Union (EU). Delegates will see and better understand how to navigate EU pharmaceutical legislation impacting on clinical trials, licensing and post-licensing phases in the life cycle of modern medicines. They will also learn many of the important scientific and technical issues on which pharmaceutical, non-clinical and clinical assessors must be reassured before approvals will be given. The learning experiences will be delivered by expert speakers with international experience and reputation. Six of the expert panel currently work or have worked within various regulatory authorities. The lectures will be supported by Mini-Workshops wherein delegates will discuss within groups various questions pertinent to the training programme; delegates' feedback will be supported by views from the panel of speakers.
Contact: Judith Black / Leigh White
Telephone: 44 1483 730071; Fax: 44 1483 730008
Email: info@management-forum.co.uk
Website: http://www.management-forum.co.uk/html/con_semin_section/con_display_event.asp?event=824
11th September 2008 - 13th September 2008 at the Stockholm (Dalarö in Dalarö, Sweden [2043]
Rosenön Meeting on Application of DMPK Principles in Evaluation of Drug Safety
The topic of this year’s Rosenön Meeting is “Application of DMPK principles in evaluation of Drug Safety”. The preliminary program includes sessions on DMPK aspects of drug safety i.e. exposure – adverse effect relationships, role of metabolites in adverse events, DMPK aspects of liver toxicity and immune-toxicity. In addition there will be dedicated sessions to biological drugs discussing DMPK principles and safety aspects of this emerging class of drugs.
The Rosenön Meeting is arranged in collaboration with the Section of Pharmacokinetics and Drug Metabolism of the The Swedish Academy of Pharmaceutical Sciences.
Contact: Jenny Hagberg
Telephone: +46 8 723 50 91; Fax: +46 8 20 55 11
Email: jenny.hagberg@lakemedelsakademin.se
Website: http://www.lakemedelsakademin.se/Rosenon2008
14th September 2008 - 16th September 2008 at the Sheraton Philadelphia City Center Hotel in Philadelphia, PA, USA [2119]
37th Annual Meeting of the American College of Clinical Pharmacology
Meeting Topics:
Pharmacology, Clinical Trials, Drug Design, Drug Development and High Cost of Drug Development, Pharmacogenomics, Clinical Pharmacology, Modeling & Simulation, Bayesian Methods in Clinical Pharmacology, Drug Events & Medication Errors
Contact: Susan Ulrich, ACCP Executive Director
Telephone: 315-768-6117; Fax: 315-768-6119
Email: SUE@ACCP1.org
Website: http://www.ACCP1.org
15th September 2008 at the The Rembrandt Hote in London, UK [2121]
EMPLOYEE /WORKER RIGHTS IN IP
In March 2007 the UK Court of Appeal clarified the issue of ownership of employee inventions in the case of LIFFE Administration and Management v Pavel Pinkava and another [2007] All ER 981. Despite the important guidance this case provided in the UK, employee/worker inventions continue to pose unique risks to employers worldwide. The primary objective of this seminar is to minimise employer risks by highlighting the key issues and demonstrating how these can be addressed. Speakers will give perspectives from the UK, Germany, Switzerland and the US.
Contact: Judith Black / Leigh White
Telephone: 44 1483 730071; Fax: 44 1483 730008
Email: info@management-forum.co.uk
Website: http://www.management-forum.co.uk/html/con_semin_section/con_display_event.asp?event=865
17th September 2008 - 18th September 2008 at the The Rembrandt Hotel
in London, United Kingdom [2122]
POTENCY TESTING EXPLAINED FOR THE VETERINARY INDUSTRY
This course has been designed to offer a practical hands-on workshop to rapidly inform you about the immunological and microbiological issues which are associated with the potency testing of veterinary vaccines. This is an excellent opportunity to experience a guide through the production of antigens for vaccines and to learn about appropriate in-process tests as well as about the requirements for potency testing of finished batches of product. By the end of the course you should have a good understanding of the terms used in the preparation of veterinary vaccines which will help you to read and prepare dossiers for Marketing Application procedures.
Contact: Judith Black / Leigh White
Telephone: 44 1483 730071; Fax: 44 1483 730008
Email: info@management-forum.co.uk
Website: http://www.management-forum.co.uk/html/con_semin_section/con_display_event.asp?event=891
17th September 2008 - 19th September 2008 at the The Rembrandt Hotel
in London, UK [2123]
PHARMA MINI MBA ~ Autumn School
This intensive three day course covers the key areas of an MBA and applies these MBA tools and concepts to the Bio/Pharmaceutical industry, providing you with a firm foundation of the essential MBA thinking and terminology. Three modules will be covered in just three days of workshops minimising disruption to your normal work. To enhance the value of the course and minimise your time away from the office there is also optional pre and post-work set by the tutors (at no extra cost).
Contact: Judith Black / Leigh White
Telephone: 44 1483 730071; Fax: 44 1483 730008
Email: info@management-forum.co.uk
Website: http://www.management-forum.co.uk/html/con_semin_section/con_display_event.asp?event=879
18th September 2008 - 19th September 2008 at the The Rembrandt Hotel in London, United Kingdom [2140]
MEDICAL DEVICE CLINICAL INVESTIGATIONS AND EVALUATIONS
This course has been designed specifically for those involved in gathering clinical data to support regulatory approval and marketing of medical devices. With the recent amendments to the Medical Device Directives there are more stringent requirements to ensure the quality of the data submitted for CE marking of devices, and the data which needs to be generated once the device is on the market.
Contact: Judith Black / Leigh White
Telephone: 44 1483 730071; Fax: 44 1483 730008
Email: info@management-forum.co.uk
Website: http://www.management-forum.co.uk/html/con_semin_section/con_display_event.asp?event=892
18th September 2008 - 19th September 2008 at the Harrington Hall Hotel in London, UK [2124]
A PRACTICAL INTRODUCTION TO INTERNATIONAL PATENT LAW AND PRACTICE
This course has been designed to provide a one-stop, comprehensive, practical introduction to international patent law for people whose work involves IP. By broadening their overall knowledge of the complex world of patents it will enable them to work more effectively and with greater understanding. The course will outline the basic steps required to obtain a typical patent, and consider infringement and litigation. The role of patents as property, patent portfolio management and the principles of licensing will also be outlined and explained.
Contact: Judith Black / Leigh White
Telephone: 44 1483 730071; Fax: 44 1483 730008
Email: info@management-forum.co.uk
Website: