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Session Chair(s)
Thijs Giezen, PHARMD, PHD, MSC
Medicines Evaluation Board, Netherlands
Speaker(s)
EBG perspective
Elke Grooten, MPHARM
Novartis, Belgium
Head EU Relations
Beyond Extrapolation: the Value of Pharmacology and Innovative Study Designs
Malte Peters
Sandoz, Switzerland
Global Head Clinical Development Biopharmaceuticals
Special Considerations for the Pharmacovigilance of Biologics
Xavier Kurz, MD, PHD, MSC
European Medicines Agency, Netherlands
Head of Data Analytics Workstream
Identification and Traceability of Biologicals – Case Study From the Netherlands
Pieter Stolk, PHARMD, PHD
University Medical Centre Utrecht, Netherlands
Project Manager
WHO Biologic Qualifier: an Opportunity to Advance Global Identification and Pharmacovigilance
Raffaella Giovanna Balocco Mattavelli, PHARMD, PHD
World Health Organization (WHO), Switzerland
Group Lead, International Nonproprietary Name Programme