Biosimilars Conference 2015

This conference discusses biosimilars in the EU and internationally, with a focus on both regulatory and scientific challenges as well as market access and experiences.

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Session 3 Continued

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)

EuropaBio Survey of Physician Preferences for Information Sources and Contents of a Biosimilar Label (SmPC) in 7 EU Member States (2015)

Keith Watson, PhD

Director, Global Regulatory Affairs, Biologics Strategic Development, AbbVie Ltd, United Kingdom

Panel Discussion

Elena Wolff-Holz, MD, PhD

Chair, Biosimilar Medicinal Products Working Party (BMWP) of CHMP; Assessor, Paul-Ehrlich Institut, Germany

Xavier Kurz, MD, PhD, MSc

Head of Data Analytics Workstream, European Medicines Agency, Netherlands

Raffaella Giovanna Balocco Mattavelli, PharmD, PhD

Group Lead, International Nonproprietary Name Programme, World Health Organization (WHO), Switzerland

Pieter Stolk, PharmD, PhD

Project Manager, University Medical Centre Utrecht, Netherlands

Elke Grooten, MPharm

Head EU Relations, Novartis, Belgium