Session: B1: Supply Chain Collaboration and Product Approvals during a Pandemic

Live Q&A (B1)

Monday, September 27, 2021

14:17 – 15:00 EDT

As treatments for COVID-19 infections were deployed during the pandemic, we were faced with challenges in drug supply of life saving medicines. Some countries enacted export bans of certain drugs, and other factors including plant staffing caused strains on the existing supply chains of APIs, raw materials, and finished drug products. Pandemic travel bans limited inspections of drug manufacturing facilities. We will examine the effect of the pandemic on drug supply chain and drug applications. The session will include regulatory experiences with EUAs and how use of tools such as remote assessments provided insight into facilities named in drug applications.

Moderator(s)

Paul Z. Balcer

Program Manager, CDER
U.S. FDA
Arvada, Colorado, United States

Panelist(s)

Pat C. O'Sullivan, MBA

Vice President Supply Chain for Sanofi Genzyme
Sanofi
Cobh , Cork, Ireland

Regulatory Panelist(s)

Mahesh R. Ramanadham, PharmD, MBA

Associate Director Scientific Operations, CDER
U.S. FDA
Highland, Maryland, United States