Learning Tracks

This session will include a discussion of how manufacturers and regulators can think about how to balance extractables and leachables with patient access to medicines. Specifically, considerations for extractables and leachables during the manufacturing process and approaches for assessment and qualification will be discussed.

Moderator: Giuseppe Randazzo
Senior Vice President, Sciences and Regulatory Affairs, AAM

Vince Crowley, PhD
Senior Pharmacologist, Division of Pharmacology/Toxicology Review (DPTR), OSCE, OGD, CDER, Food and Drug Administration

Priti Jagani
Senior Director, Pharma R&D, Amneal Pharmaceuticals

Edwin Jao, PhD
Director, Division of Pharmaceutical Manufacturing Assessment IV, OPMA, OPQ, CDER, Food and Drug Administration

Alan Thompson
Director, Inhalation Regulatory Affairs, Teva Pharmaceuticals