Roundtable Regulatory Affairs

Swissmedic and the pharmaceutical industry meet regularly to discuss topics relating to the regulation of medicinal products at a Round Table on Regulatory Affairs (referred to below as the "Round Table”). The Round Table enables the parties to make their concerns heard in order to respond promptly and appropriately to regulatory and technical signals, as necessary. There are cases in which Swissmedic needs to discuss a change in the regulation of medicinal products with representatives of the pharmaceutical industry before the change is made, so that practical aspects of operational implementation can be properly taken into account and communicated appropriately to the target audience.

The Round Table comprises representatives of the pharmaceutical industry and its associations plus senior representatives of the Authorisation division at Swissmedic. Over the years, the direct exchange between Swissmedic and the pharmaceutical industry has proved to be a productive way of promoting mutual understanding of the parties’ concerns as well as for planning and implementing regulatory, process-related and technical changes in an efficient manner. Separate Round Tables have been established to address issues relating to veterinary medicinal products as well as complementary and herbal medicines.

The Round Table’s guidelines for cooperation are set out in the Terms of Reference.

Industry participants

A maximum of 12 representatives of the pharmaceutical industry, who are familiar with operational issues in the pharmaceutical industry on the basis of their day-to-day work or many years of experience, will take part in the Round Table. They will also need to have in-depth knowledge of the legislation, the political environment and the working methods of Swissmedic.

The associations will agree among themselves on their representatives at the Round Table. If you are interested in taking part, please first contact anfragen@swissmedic.ch

The following people currently participate in the Round Table:

Name Company / Association
Sibylle Baerni, dipl. pharm. GlaxoSmithKline; Interpharma
Dr Lukas Brand Novartis Pharma Schweiz AG; Interpharma
Annette Fichtel-Dasen, dipl. biol. II Abbvie; Interpharma
Jürg Granwehr, lawyer scienceindustries
Dr Sergio Mantelli 
Verfora Ltd; ASSGP
Dr Axel Müller
CEO Intergenerika
Dr Markus Müller Astellas Pharma; vips
Dr Madeleine Peter Spirig HealthCare Ltd; Intergenerika
Dr Andreas Pfenninger Interpharma
Luzia Rüdlinger, dipl. pharm. vips
Corinne Wenger, dipl. pharm. Roche Pharma (Switzerland) Ltd/Interpharma

Last modification 15.08.2019

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