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Challenges and Opportunities in Product Quality: Lifecycle Management
Session Chair(s)
Susan Rosencrance, PHD
Acting Director, Office of Generic Drugs, CDER
FDA, United States
The efficacy and safety of a drug product are linked to its quality. Assuring product quality across the product lifecycle is challenging due to the numerous changes made to maintain or enhance product quality and manufacturing efficiency. Regulatory and industry speakers in this session will describe current thinking on product quality lifecycle management.
Learning Objective : Describe FDA's current thinking on drug product quality lifecycle management, from brand name drugs to generics; Discuss specific tools and mechanisms in efficiently managing product lifecycle: Identify existing and upcoming regulatory tools to ease post approval changes.
Speaker(s)
Lifecycle Management Challenges for Accelerated Program and Possible Innovative Solutions
Lucy Chang, PHD
Merck & Co., Inc., United States
Executive Director
Opportunities for Streamlining Postapproval Lifecycle Management Under ICH Q12
Isabelle Colmagne-Poulard, PHARMD, MBA, MSC
Merck, Switzerland
Head, International Global Regulatory & Scientific Policy
Challenges and Opportunities in Lifecycle Management of Product Quality
Hasmukh Patel, PHD
FDA, United States
Director, OLDP, OPQ, CDER