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Session 3 Hot Topics – Pharmacovigilance, Identification, Traceability, Naming and Labeling for Biologicals and new Approaches to Biosimilar Development
Session Chair(s)
Thijs Giezen, PHARMD, PHD, MSC
, Medicines Evaluation Board, Netherlands
Challenges associated with pharmacovigilance, traceability, global naming for biologicals as well as new approaches to biosimilar development will be shared and debated in this session.
Speaker(s)
Elke Grooten, MPHARM
Head EU Relations, Novartis, Belgium
EBG perspective
Malte Peters
Global Head Clinical Development Biopharmaceuticals, Sandoz, Switzerland
Beyond Extrapolation: the Value of Pharmacology and Innovative Study Designs
Xavier Kurz, MD, PHD, MSC
Head of Data Analytics Workstream, European Medicines Agency, Netherlands
Special Considerations for the Pharmacovigilance of Biologics
Pieter Stolk, PHARMD, PHD
Project Manager, University Medical Centre Utrecht, Netherlands
Identification and Traceability of Biologicals – Case Study From the Netherlands
Raffaella Giovanna Balocco Mattavelli, PHARMD, PHD
Group Lead, International Nonproprietary Name Programme, World Health Organization (WHO), Switzerland
WHO Biologic Qualifier: an Opportunity to Advance Global Identification and Pharmacovigilance
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