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Session 10: Updates from Regulatory Agencies (Dossier Review/Inspections) - FDA, EMA, Other
Session Chair(s)
Moheb M. Nasr, PHD, MS
Principal
Nasr Pharma Regulatory Consulting, United States
Session 10: Updates from Regulatory Agencies (Dossier Review/Inspections) FDA, EMA and Other Global Agencies
Speaker(s)
Dr. Peter Richardson, PHD
European Medicines Agency, Netherlands
Head of Quality, Specialised Scientific Disciplines Department
Speaker Brazil:
Raphael Sanches Pereira
ANVISA, Brazil
General Manager of the Office for Medicines
Speaker Japan:
Yoshihiro Matsuda, PHD
Pharmaceuticals and Medical Devices Agency (PMDA), Japan
Senior Scientist (for Quality), Pharmacist
Speaker FDA:
Lawrence Yu, PHD
FDA, United States
Director, Office of New Drug Products, OPQ, CDER
Panel Discussion - All Participants Above and:
Anthony Ridgway, PHD
Health Canada, Canada
Acting Director, Biologics and Genetic Therapies Directorate