2011 Combination Products Workshop - P4- Clinical Trial Considerations for Combination Products

Web Code: ComboP4-11
Member/Nonmember Price: $75

Seminar Summary

Designing and executing clinical trial for combination products presents unique challenges.  This seminar aims to explore questions companies face when designing clinical programs to support the market authorization for a combination product.  Presentations will address common questions surrounding clinical trial design including sample size requirements, number and extend of clinical studies required, and claims that may be made based on the trials.  Companies will present case studies for use of drug delivery systems.

Who Should Attend

Department Operations | Regulatory Affairs | Clinical Affairs | Manufacturing | Quality| Product and Process Development Engineering | Project Management

Job Function
Individuals, at all levels, working in strategic roles in quality, regulatory, clinical and manufacturing departments in drug, biologic or medical device companies engaged in the development and manufacture of combination products

Presenters

Terry Milby, Director, Regulatory Affairs, BioMarin 

Mark Marley, Principal Advisor, Global Regulatory Affairs, CMC, Eli Lilly & Company

Carlos Mena-Grillasca, Lead Interdisciplinary Scientist, CDER, FDA

Registration contact

Jason E. Brown
Senior Programs Manager
Tel: +1 (301) 656-5900 ext. 131
Fax: +1 (301) 986-1093
Email: brown@pda.org

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