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The Global Pharmaceutical Manufacturing Leadership Forum 2021

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

May 18, 2021 10:00am ‐ May 18, 2021 11:05am


  • 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
  • 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 PIC/S Chair, Sr. Corporate Regulatory Compliance & Enforcement Advisor, Regulatory Operations and Enforcement Branch (ROEB), Health Canada
  • Kevin O'Donnell, PhD, Market Compliance Mgr & Sr Inspector, 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

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