Analytical strategies for the marketing approval in highly regulated markets

4^th International Conference and Exhibition on Biologics & Biosimilars

October 26-28, 2015 Baltimore, USA

Robert E Zoubek

Granzer Regulatory Consulting & Services, Germany

Posters-Accepted Abstracts: J Bioanal Biomed

Abstract :

With increasing experience with Biosimilars also the regulator�s perspective has further evolved and is based on a fresh scientific principle. The author will provide the latest insights from interactions with regulators worldwide. He will present the current thinking regarding the analytical requirements of both, EMA and FDA. He will highlight the key requirements of today�s Biosimilars development and exemplify different strategies to obtain marketing approval.

Biography :

Email: zoubek@granzer.biz