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Session 5: Pharmacovigilance
Session Chair(s)
Thijs Giezen, PharmD, PhD, MSc
Medicines Evaluation Board, Netherlands
The session will address recent developments and experiences in the field of pharmacovigilance of biologics, including biosimilars. Topics covered include the Guidance on Good Vigilance Practice for biologics, experiences with post-authorization studies with biosimilars and traceability, including examples of hands-on-experiences in clinical practice.
Speaker(s)
GVP for Biologics and Eudravigilance Database – Update of new Processes and Impact on Biosimilars
Niels Vermeer
European Medicines Agency, Netherlands
Detached national expert, Pharmacovigilance and Epidemiology Department
PASS - Practical View and Case Studies
Yun Gu, RPh
Pfizer Inc., United States
Good Practice with Registries for Biologics and Biosimilars
Michael Busch-Sørensen
Danish Society for Pharmacoepidemiology, Denmark
Board Member
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