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Learning Tracks

The Post-COVID Inspection World: New Tools, Lessons Learned and Future Challenges

Monday, November 8, 2021

1:00 p.m. - 2:30 p.m.

Over its history, FDA has responded to public health emergencies by innovating and changing how it regulates.  During the COVID pandemic, FDA adopted new tools and developed new ways of interacting with and overseeing industry. Inspections presented a particular challenge for FDA.  Historically, in-person evaluations have played an important role in the assessment of drug applications and of post-market quality.  With physical inspections proving impossible, to varying degrees, FDA relied on additional tools, such as record requests, inspections by trusted foreign regulators and, more recently, remote interactive evaluations.  Some of these changes were driven by the necessity of reviewing applications, but others build on previous work that FDA embarked on when implementing the Food and Drug Administration Safety and Innovation Act.

FDA will be able to resume physical inspections as the pandemic wanes.  However, the agency faces a daunting backlog of applications.  Some of the inspection alternatives that FDA has been using allow the agency to oversee some facilities and clinical research more efficiently than do physical inspections.  Will FDA continue to use some of these tools and how will it cope with the expected application backlog?

Moderator: Howard Sklamberg
Partner, Arnold & Porter

Lynne Ensor, PhD
Vice President, RCS Head of Global Compliance, Paraxel International

Laurie Graham 
Division Director, Division of Internal Policies and Programs, Office of Policy for Pharmaceutical Quality, OPQ, CDER, FDA

Rachel Harrington 
Consumer Safety Officer, Office of Medical Products and Tobacco Operations (OMPTO), ORA, FDA

Bob Iser, MS
Senior Vice President, Global Quality Management, Amneal Pharmaceuticals

Sean Kassim, PhD
Director, Office of Transactional Sciences (OTS), Office of Study Integrity and Surveillance, CDER, FDA

Derek Smith, PhD 

Deputy Director, Office of Pharmaceutical Manufacturing Assessment, OPQ, CDER, FDA

Jude Vethanayagam
Global Director, Corporate Quality Audit & Global Supplier Quality, Apotex Inc.

CAPT Leo Zadecky, RPh, MS
Senior Regulatory Review Officer, Drug Shortage Staff, CDER, FDA

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