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Robert E. Zoubek

GRC&S, Germany

Title: Analytical strategies for the Marketing Approval in highly regulated markets

Biography

Biography: Robert E. Zoubek

Abstract

- Rational for the analytical toolbox - Sources of information to justify your analytical strategy - The way forward: The right strategy to prove biosimilarity - Minor differences:How similar is similar enough? With increasing experience with Biosimilars also the regulator′s perspective has further evolved andn is based on a fresh scientific principle. Robert 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.