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 1: Regulatory Outlook for Europe

Session Chair(s)

Aimad Torqui

Division Head Medicines Evaluation Board

Medicines Evaluation Board, Netherlands

The session will discuss recent developments and future prospects in the EU regulatory landscape and their practical implications for development and approval of biosimilars.

Speaker(s)

Overview of the Immunogenicity Guideline

Venke Skibeli

Norwegian Medicines Agency, Norway

Other guidelines under revision and future trends

Thijs Giezen, PharmD, PhD, MSc

Medicines Evaluation Board, Netherlands

Biosimilars for Rare Diseases

Richard L Dicicco

Harvest Moon Pharmaceuticals, United States

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