Goals and Objectives
The role of stability in today’s pharmaceutical development process and ongoing manufacturing environment is increasingly complex. Development and quality scientists are faced with many challenges including how to develop methodologies that predict stability, assessing stability for increasingly complex drug products, the role of QbD, diverse regulations in world-wide markets, and the continuous pressure to reduce costs. This workshop will bring together scientists and regulators from around the world to discuss current requirements, and best practices to address these challenges:
- stability by design and using predictive tools to develop stable pharmaceutical products;
- stability strategies and factors in design/formulation for drug device combinations;
- regulatory harmonization of world-wide stability requirements - WHO Stability Guideline, emerging markets, globalization;
- stability strategies for protein and biotech products;
- applications of new technologies to stability evaluation; and
- case studies.
Special Announcements
Register by August 26, 2009
and save!- When you register you will also be entered into a prize drawing for a copy of the Stability Handbook ($179 value).
Planning Committee Members
Abbie Gentry, Ph.D., McNeil Consumer Healthcare, Co-chair
Dilip Choudhury, Ph.D., Allergan, Inc., Co-chair
Mark Alasandro, Ph.D., Merck
Steven Baertschi, Ph.D., Eli Lilly and Company
Stephen Colgan, Ph.D., Pfizer
Frank Diana, Ph.D., Endo Pharmaceuticals
Kim Huynh-Ba, M.Sc., Pharmalytik
Karen Lucas, Johnson & Johnson
Nanda Subbaro, Ph.D., Biologics Consulting
Saji Thomas, M.S., Par Pharmaceutical
Paula Youngberg Webb, M.Sc., Baxter Healthcare
Manuel Zahn, Ph.D., 3R Consultants
Melvin H. Weinswig, Ph.D., University of Wisconsin-Madison