Regulatory Changes During a Pandemic (CMC /Inspections and Reviews) Panel Discussion

Speaker(s):

• Joseph Famulare, Vice President, Global Quality Compliance and External Relations, Genentech, A Member of the Roche Group
• Elizabeth Miller, Pharm.D., Assistant Commissioner for Medical Products and Tobacco Operations, FDA/ORA
• Ms. Valerie E. Jensen, CAPT (Ret.), RPh, Associate Director, Drug Shortage Staff, CDER/FDA
• Francis Godwin, Office Director, OMQ, OC, CDER, FDA
• Paul A. Gustafson, 2022-2023 PIC/S Chair, Sr. Corporate Regulatory Compliance & Enforcement Advisor, Regulatory Operations and Enforcement Branch (ROEB), Health Canada
• Kevin O'Donnell, PhD, Market Compliance Manager, Health Products Regulatory Authority (HPRA)
• David Churchward, Global Head Sterility Assurance, Cell and Gene Technologies, Lonza Biologics
• Stelios C. Tsinontides, Ph.D., FAIChE, Director, Office of Pharmaceutical Manufacturing Assessment (OPMA), OPQ, CDER, FDA