Roundtable on GMP/GDP Inspectorates and Licences

Swissmedic and the pharmaceutical industry meet regularly to discuss topics relating to GMP/GDP and establishment licences at a Round Table on GMP/GDP (referred to below as the "Round Table”). The Round Table enables all parties to make their concerns heard in order to respond promptly and appropriately to regulatory and technical signals, as necessary. For Swissmedic the Round Table is a platform for exchanging information and experience on a technical level. Changes in the field of GMP/GDP are discussed 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 regional inspectorates and senior representatives of the Inspectorates and Licences Department at Swissmedic. 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.

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

Industry participants

A maximum of 15 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 are also required to have in-depth knowledge of GMP/GDP.

The associations will agree among themselves on their representatives at the Round Table.

The following people currently participate in the Round Table:

Name Association
Dr. Sergio Mantelli ASSGP
Dr. Serge Carel GRIP
Nicole Arnold Interpharma
Dr. Sibylle Koller-Lucae Intergenerika
Dr. Magdalena Luther Intergenerika
René Jenny Pharmalog
Dr. Susanne Hofstetter scienceindustries
Andrea Schwabl SVKH
Dipl. pharm. Luzia Rüdlinger VIPS
Dipl. chem. Marie-Louise Gachnang VIPS
Dipl. pharm. Salvatore Volante Interest group of Swiss pharmaceutical SMEs
Dr. Michael Altorfer Swiss Biotech Association
Dr. med. Konrade von Bremen Radiopharma
Dr. Beatrice Oberle-Rolle RDAF Rare Disease Action Forum
Reto Müller scienceindustries
SPoC (contact for associations)

Swissmedic usually plans to organise two such meetings each year.