- email:registrations@informa-ls.com
- phone:+44(0)20 7017 7481
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Stability Testing for Pharmaceuticals 2012
21 - 22 March 2012
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Stability Testing for Pharmaceuticals
Best practices for stability testing in-line with ICH guidelines
Stability testing forms a critical component in the drug development process. At Stability Testing for Pharmaceuticals 2012 you will have the opportunity to discuss best practices in stability testing with experts and peers. With time and resource savings a key driving factor for pharmaceutical companies, from this conference you will learn on the benefits of incorporating design of experiment concepts into your stability protocol.
2012 Stability Testing for Pharmaceuticals conference highlights: Including assessing advances in stability tests, how to develop a stability protocol across a global market, examining regulatory stability requirements outside ICH, practical advice on improving GMP audit success (including what can go wrong in stability laboratories and with laboratory results)
PROGRAMME OVERVIEW
- Regulatory Perspective on Stability Testing
- Managing Global Stability Requirements
- Temperature Excursion and Transport Studies
- Considerations in Chemical Stability
- Trends in Physical Stability
- Analysis of Decomposition Products
- Stability Testing for Drug-Device Combination Products
How to develop a stability protocol across a global market – critical insights on how to cover multiple country requirements with minimal stability tests
Discuss stability testing requirements outside of the ICH – including current classification of countries into climate zones according to the WHO stability guideline
Gain an understanding of what can go wrong in stability laboratories and with laboratory results - take away key strategies for GMP audit success
Gain and understanding of stability requirements for drug-device combination products – including developing suitable methods and regulatory requirements
Discuss how forced degradation can be used to understand chemical instabilities and the generation of realistic forced degradation products
Get up-to-speed with changes to the ‘Good Distribution Practice’ guideline including current requirements for the transport of medicinal products and what this means for your stability protocols
Learn from real-life case studies how shelf-life was justified during a temperature excursion using lab data
Stability Testing 2012 Speakers
Stability Testing 2012 Speakers
Dr Manuel Zahn
Managing Director
3R Pharma Consulting
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Thomas Dries
Market Development Manager
Honeywell
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Gülcan Benzer
R&D Stability Supervisor
Abdi Ibrahim
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Douglass Mead
Director, Global Regulatory Affairs - CMC, Medical Devices and Combination Products
Janssen Research & Development
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SPOTLIGHT SESSION SPONSOR
Media Partners
Practical Application of Statistics: Evaluating Stability Data
Supporting filings using accelerated stability data
Led by:
Ken Waterman, President, FreeThink Technologies Inc, USA
Introduction to statistical evaluation of stability data: What you always wanted to understand
Led by:
Manuel Zahn, Managing Director, 3R Pharma Consulting GmbH, Germany
Albert Chau, Director, Datacision Limited, United Kingdom
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Spotlight Session Sponsors
Dates and Venues
21 Mar 2012 - 22 Mar 2012
Radisson Blu Hotel, Berlin
