Learning Tracks

In this session, FDA representatives will present best practices to be followed in communications with DMFs, REMS, and the use of post-submission meetings to facilitate more timely approvals in generic applications. Industry presenters will offer their perspectives on review consistency and their experiences with DMFs, REMs, and the use of post-submission meetings.

Rashmi V. Shetty, MSc.
Director, Regulatory Affairs, Cipla LTD

CAPT Stacy Barley RN, MSN, MHA
Lead REMS Coordinator, Division of Clinical Safety and Surveillance (DCSS), OSCE, OGD, CDER, Food and Drug Administration

Jayani Perera, PhD
Senior Chemist, Division of Product Quality Assessment XIX, OPQA III, OPQ, CDER, Food and Drug Administration

Diana Vivian, PhD
Associate Director, Division of Bioequivalence II (DB II), OB, OGD, CDER, Food and Drug Administration

Panelist: Srinivas Gurram
Senior Vice President of Regulatory Affairs & Corporate QA Lead, Americas, Zydus Pharmaceuticals