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

Session Leader(s):

• Betsy P. Fritschel, Director, Regulatory Compliance, Johnson & Johnson

Moderator(s):

• Sarah C. Pope Miksinski, PhD, Executive Director, CMC Regulatory Affairs, Gilead Sciences, Inc.

Speaker(s):

• Roberto Conocchia, GMP Technical Lead, 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
• Dr. Jennifer Maguire, PhD, Director of the Office of Quality Surveillance, CDER/FDA
• Ewan Norton, Lead Senior GMDP Inspector, MHRA
• Mahesh R. Ramanadham, Pharm.D./M.B.A., Deputy Director, FDA/CDER/OPQ/OPPQ
• 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