Roundtable eCTD

Swissmedic and the pharmaceutical industry meet regularly to discuss topics relating to eCTD at an “eCTD Round Table”. This Round Table provides participants with a platform on which they can share information and experience, helping them in particular to continue developing processes and systems for the electronic submission of applications in a coordinated and practice-oriented way.

The Round Table comprises representatives of the pharmaceutical industry and of Swissmedic (Operational Support Service department plus IT specialists where required). 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 formulating and implementing 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

The Round Table is attended by up to 12 representatives of the pharmaceutical industry who are familiar with the technology and processes associated with application submission – and eCTD in particular – as a result of their day-to-day work and experience.

The following people currently participate in the Round Table:

Name Company/association
Christine Aigner Max Zeller Söhne AG
Karin Barker MSD Merck Sharp & Dohme AG
M.Sc. Marcel Burger Novartis Pharma AG
Dr. Monika Dahms Gilead Sciences Switzerland Sàrl
Dipl. chem. Marie-Louise Gachnang Eisai Pharma AG
M.Sc. Dario Andenmatten Bayer (Schweiz) AG
Dr. Anja Gödl Pfizer AG
Dipl. pharm. Jürg Häusler Bristol-Myers Squibb SA
Dr. Roger Bolten Intergenerika/Mepha Pharma AG
Dipl. pharm. Micheline Berger Roche Pharma Schweiz AG
Dr. sc. Michael Räz CSL-Behring AG

Summary of the working group meetings (in German)