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Session 10: Regulators Update
Session Chair(s)
Moheb M. Nasr, PhD, MS
Principal
Nasr Pharma Regulatory Consulting, United States
To conclude the workshop, this last session will provide updates from experts from regulatory agencies as well as a true opportunity for a dialogue with the audience.
Speaker(s)
Speaker
Issei Takayama, DrSc
Pharmaceuticals and Medical Devices Agency (PMDA), Japan, Japan
Reviewer, Office of New Drug IV
Speaker
Jean-Louis Robert, PhD
Luxembourg
Former CHMP/CVMP QWP Chair
Speaker
Peter Richardson, PhD
European Medicines Agency, Netherlands
Head of Quality, Specialised Scientific Disciplines Department
Speaker
Anthony Ridgway, PhD
Health Canada, Canada
Acting Director, Biologics and Genetic Therapies Directorate
Speaker
Sarah Pope Miksinski, PhD
Gilead Sciences, United States
Executive Director, CMC Regulatory Affairs
Speaker
Helen Yejin Saccone, PharmD
FDA, United States
Associate Director, Global Regulatory Policy, GO, OC