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Session Chair(s)
Bijal Pandhi, PHARMD
Senior Global Program Regulatory Manager
Novartis Pharmaceuticals Corporation, United States
Learning Objective : Define a general understanding of the challenges of late product life cycle management; Describe a perspective of how industry and regulators manage these challenges; Restate a recent case study that provides examples of managing such changes (benefit-risk review of calcitonin-salmon drug class).
Speaker(s)
Industry Perspective
Paul Aftring, MD, PHD
Novartis Pharmaceuticals Corporation, United States
Global Program Head, Established Medicines
FDA Perspective
Theresa Kehoe, MD
FDA, United States
Director, Division of General Endocrinology (DGE), OND, CDER
Development of An Integrated Response
Steven M. Weisman, PHD
Lumanity Inc, United States
Global President, Clinical and Regulatory
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