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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)
Peter Richardson, PhD
European Medicines Agency, Netherlands
Head of Quality, Specialised Scientific Disciplines Department
Speaker Brazil:
Raphael Sanches Pereira
ANVISA, Brazil
Quality Assessment of Synthetic Medicines Office Manager
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
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