Regulatory Panel Discussion

Speaker(s):

• 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