Stephan K. Roenninger

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Stephan K. Roenninger is head of External Affairs Europe, Amgen (Europe) GmbH, Rotkreuz, Switzerland.

Articles

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Reliance-Based Waivers Become the Predominant Trend in In-Country Testing of Pharmaceutical Products

Joerg H.O. Garbe;Tais Conti;Mic McGoldrick;Maria G. Jacobs;Philippe Juvin;Peter J. Mlynarczyk;Mark van Ooij;Stephan K. Roenninger;Gerald Tyers
May 8th 2024

This study reviews changes in in-country testing (registration testing, import testing) requirements and analyzes current trends. In the context of international harmonization of good practices and standards as well as the improved information exchange between national regulatory authorities, in-country testing is considered outdated and redundant in many cases.

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