Learning Tracks

How Has the COVID-19 Pandemic Shaped FDA Inspections and What’s on the Horizon?

Tuesday, November 8, 2022

3:00 p.m. - 4:00 p.m.

The COVID-19 public health emergency created many challenges for inspections of pharmaceutical manufacturers, resulting in delays for generic drug and biosimilar applications. This session will explore the challenges and potential solutions related to bringing generic drugs and biosimilars to market due to inspection delays caused by the COVID-19 pandemic. FDA will share an overview of FDA’s “Resiliency Roadmap for Inspectional Oversight” in view of the COVID-19 backlog imposed inspections and how the Agency is making use of alternative tools to on-site PAI inspections to alleviate the backlog. Representatives from industry will share their perspectives on the challenges companies continue to face regarding inspections and discuss potential solutions for inspections to ensure patient access to generic drugs and biosimilars is not stalled.

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

Alonza Cruse 

Director, ORA, FDA

Rajeev Mathur
Senior Vice President and Head Global Regulatory and Business Continuity, Sun Pharma

Stelios Tsinontides, PhD, FAIChE 
Director, Office of Pharmaceutical Manufacturing Assessment (OPMA), OPQ, CDER, FDA

Arlene Wolny, PhD
Sandoz Head U.S. Regulatory Affairs Biosimilars, Sandoz Inc.