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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
Senior Quality Specialist, European Medicines Agency, Netherlands
Raphael Sanches Pereira
General Manager of the Office for Medicines, ANVISA, Brazil
Speaker Brazil:
Yoshihiro Matsuda, DrMed
Principal Senior Scientist (for Quality), Pharmacist, Pharmaceuticals and Medical Devices Agency (PMDA), Japan
Speaker Japan:
Lawrence Yu, PhD
Director, Office of New Drug Products, OPQ, CDER, FDA , United States
Speaker FDA:
Anthony Ridgway, PhD
Acting Director, Biologics and Genetic Therapies Directorate, Health Canada, Canada
Panel Discussion - All Participants Above and:
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