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2021 Global Pharmaceutical Regulatory Summit

Regulatory Panel Discussion

Apr 28, 2021 9:25am ‐ Apr 28, 2021 11:25am


  • Thomas B. Hartman, President and CEO, ISPE
  • Thomas Zimmer, PhD, VP, European Operations, ISPE
  • Carmelo Rosa, PsyD, Director, Division of Drug Quality I, FDA/CDER/OC/OMQ
  • Manuel Ibarra Lorente, Head of Pharmaceutical Inspection & Enforcement,, Spanish Agency of Medicines and Healthcare Products
  • Vladislav Shestakov, Deputy Head of the Russian State GMP Inspectorate, Russia State Institute of Drugs and Good Practices
  • Klaus Eichmueller, Darmstadt Regional Council, Regierungspräsidium Darmstadt
  • Jacques Morenas, Technical Advisor of the Inspection Division Director, ANSM
  • Joey Gouws, PhD, Team Lead, Inspection Services, Prequalification Team, World Health Organization
  • Anne Hayes, Inspection Manager, Compliance and PIC/S Chair, HPRA and PIC/S Chair
  • David Churchward, Global Head Sterility Assurance, Cell and Gene Technologies, Lonza Biologics
  • Brendan Cuddy, Lead Scientific Officer, EMA
  • Marisa Delbo, Head of Risk Management Office, AIFA
  • Alonza Cruse, Director, Office of Pharmaceutical Quality Operations, FDA/ORA

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