Robert E. Zoubek
Granzer Regulatory Consulting & Services, Germany
Title: Regulatory strategies for the European Marketing Approval
Biography
Biography: Robert E. Zoubek
Abstract
The Five requirements to be fulfilled - Different strategies exemplified - How you get your strategy validated - Why companies fail European regulators have been the first to develop Biosimilar Guidance and approve in an abbreviated route products which are highly similar compared to their originator. However, with increasing experience with Biosimilars also the regulator′s perspective has further evolved enabling sponsors more flexibility in their development. Robert will provide insights into the interaction with regulators and how you should seek for validation of your development strategy. He will highlight the key requirements of today′s Biosimilars development and exemplify different strategies to obtain marketing approval in Europe.