CHAIR
:
SPEAKER
(S):
John Purves, , Head of Sector, EMEA European Medicines Agency
Nicolas Rossignol, Administrator, European Commission, DG Enterprise and Industry
Thomas Bols, Director Government Affairs & and Chairman of EuropaBio Biosimilar Working Group, Amgen USA/Europe
Ajaz S. Hussain, Vice President & Global Head of Biopharmaceutical Development, Sandoz, USA
Andrea Rappagliosi, Chairman of Healthcare Council and Vice President, EuropaBio
Description
"Biosimilars" (follow-on biologics) are an emerging field of biotechnology in the global market, and the first products are being authorized. Regulatory and industry leaders will describe and discuss Europe's approach to regulating the assessment and authorization of these complex products, as well as the market realities likely to shape this field over the next 5–10 years.
Objectives:
Understand the European Union's regulatory approach to biosimilars.
Understand the market realities likely to shape this new field of biotechnology.
Stimulate interactive discussion among regulators, industry and attendees.