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2021 ISPE Annual Meeting & Expo

Global Regulatory Town Hall: Global Regulatory Insights on Current Issues – Harmonization and Convergence


Nov 3, 2021 9:00am ‐ Nov 3, 2021 11:00am


Session Leader(s):

Moderator(s):

Speaker(s):

  • Roberto Conocchia, Senior GMP Inspector, European Medicines Agency (EMA)
  • Tara R. Gooen Bizjak, CDR, Senior Science Policy Advisor, Office of Policy for Pharmaceutical Quality, OPQ/CDER, FDA
  • Joey Gouws, PhD, Team Lead, Inspection Services, Prequalification Team, World Health Organization
  • Ian Jackson, Unit Manager, Inspection Risk, Control and Governance, MHRA
  • Jennifer Maguire, PhD, Deputy Director, Office of Quality Surveillance, CDER/FDA
  • Ewan Norton, Lead Senior GMDP Inspector, MHRA
  • Mahesh R. Ramanadham, Pharm.D./M.B.A., R.P, Associate Director for Scientific Operations, FDA/OPMA/OPQ
  • Ian Rees, Unit Manager Inspectorate Strategy & Innovation, MHRA
  • Raphael Sanches Pereira, Health Regulation and Surveillance Specialist, Anvisa
  • Lawrence X. Yu, PhD, Director, Office of New Drug Products, OPQ/CDER/FDA

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