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 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)

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

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