4th European Biosimilars Conference

As the 4th conference of its kind, the 2016 programme gives a complete 360-degree overview of biosimilar medicines. Participants will leave the conference with a wealth of new information and an expanded network of contacts.

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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

Detached national expert, Pharmacovigilance and Epidemiology Department, European Medicines Agency, Netherlands

PASS - Practical View and Case Studies

Yun Gu, RPh

, Pfizer Inc., United States

Good Practice with Registries for Biologics and Biosimilars

Michael Busch-Sørensen

Board Member, Danish Society for Pharmacoepidemiology, Denmark