Learning Tracks

This session will explore inspection-related challenges and opportunities for increased efficiencies in the review of generics and biosimilars applications. This will touch on both domestic and foreign inspections, including FDA’s recent news of increased, unannounced inspections overseas. Discussion also will touch on challenges related to facility inspections identified late in the review cycle, and opportunities for FDA and industry collaboration to minimize such outcomes.

Participants:

Christopher Downey, PhD
Director, Division of Pharmaceutical Manufacturing Assessment VI (DPMA VI) OPMA, OPQ, CDER, FDA

Joseph De Vito, PharmD
Senior Director, Global Quality Audits and Compliance, Teva Pharmaceuticals

Rajeev Mathur, PhD
Head Global Regulatory & Business Continuity, Sun Pharma

Ivy Sweeney, PhD
Acting Office Director, Office of Human and Animal Drug Inspectorate, OII, FDA

Arlene Wolny, PhD
Global Head, Regulatory Affairs, Biocon Biologics

Moderator: Laura Harner, MS
Associate Director, RA Biopharma, Sandoz