Good Manufacturing Practice 2024
Swiss/FDA Mutual Recognition Agreement – State of Play

Thursday, November 14, 2024

Sidley Speakers

James R. JohnsonEva von Mühlenen

Join us in Basel, where Sidley and thought leaders will be discussing the FDA and Swissmedic Mutual Recognition Agreement on Good Manufacturing Practices for pharmaceutical products. This agreement aims to streamline regulatory processes and enhance cooperation between the two countries by recognizing each other’s GMP inspections, thereby reducing the need for duplicative inspections.

We will discuss early experiences with the new framework — both positive outcomes and challenges — highlighting valuable lessons learned and exploring potential for future developments.

Topics will include:

• FDA/Swiss Mutual Recognition Agreement
• AI and Good Manufacturing Practice
• EU’s New Revised Annex 1

Featured speakers:

• Christian Schärer, Head of Inspectorate, Swissmedic, (keynote speaker)
• Oliver Schläfli, Senior Vice President Global Quality, Lonza
• Jay Jariwala, Senior Director Regulatory Compliance, Sidley
• James Johnson, Partner, Sidley
• Eva von Mühlenen, Senior Advisor, Sidley

WHO SHOULD ATTEND?

Executives, in-house counsel, quality and compliance managers and officers interested in and/or facing GMP compliance and quality management challenges in Switzerland.

For more information or questions, please contact gvaevents@sidley.com.