Swissmedic Symposium Clinical Trials


Tuesday, 4 November 2025

Welle 7 (Deck 3), next to Bern main station


directly at Bern railway station, exit Welle (Schanzenstrasse 5, Bern)

About the symposium

We are delighted to invite you to this year's Clinical Trials Symposium. The symposium is dedicated to current topics relating to clinical trials. You can look forward to exciting presentations by Swissmedic employees who are very familiar with the challenges in this area, highlight trends and provide insights into future developments.

In the afternoon, we will dive deeper into specific topics in four different workshops. Each workshop will last 90 minutes and will take place in parallel. You have the opportunity to take part in two workshops of your choice.

You have the opportunity to ask questions before the symposium. If possible, we will answer them in the Question and Answer session.

Interested? Then please register using the registration form. The registration deadline is 1 October 2025.


Participation

Participation at this symposium is per invitation only. 1 to 3 persons per invited organization can participate and should subsequently be able to train additional persons at their local level (according to the principle "Train the Trainer").

If the symposium is fully booked, Swissmedic reserves the right to decline registrations from organizations that have registered more than two participants. This is to ensure that as many interested organizations as possible have the opportunity to attend the event. Affected individuals will be contacted four weeks prior to the event.

A participation fee of CHF 350.00 + VAT (including coffee breaks and lunch) will be charged per person. Swissmedic will send an invoice to the address given in the registration.


Administrative information

  • Conference language: As participants from all regions of Switzerland are invited, all presentations and discussions will be held in English.

  • Registration: please fill in the registration form

  • Costs: CHF 350.00 VAT

  • Registration deadline: 01.10.2025 or when the event is fully booked.

  • All presentations will be made available after the event. A link will be e-mailed to all participants.

  • All registered participants will receive an e-mail with a certificate of participation after the event.

Agenda

November 4
08:30
Registration & Welcome Coffee

09:00
Opening and Introduction

Dr Simone Ferbitz

Head of Division Clinical Trials

09:15
General Aspects to Consider for FIH/Early Phase I Clinical Trials with Medicinal Products

Isabelle Meienberger

GCP/GVP Inspector

09:30
Expectations on Computerised Systems

Dr Reto Iannaccone

GCP/GVP Inspector

09:55
Frequent Inspection Findings

Dr Mario Baresic

GCP/GVP Inspector

10:15
Coffee Break & Networking

10:45
1 Year ClinO Revision

Dr Catherine Berset Kipouros

Clinical Study Assessors

11:15
Key Take Aways for Clinical Trial Submissions

Dr Carmen Campanile
Patricia Plattner

Clinical Study Assessors

11:45
Questions & Answers

Team Division Clinical Trials

12:00
Lunch Break & Networking

13:15
Workshops 1st round

Workshops are carried out in parallel and each Workshop will be held twice. Therefore, you can participate in 2 different Workshops.


Workshop 1: Staying Connected, Staying Compliant – ICH GCP Requirements Related to the Use of Electronic Devices


GCP/GVP Inspectors:

  • Dr Ruth Hinrichs

  • Denis Mosimann


Workshop 2: From Findings to Fixes: Swissmedic Perspective on CAPA Plans

GCP/GVP Inspectors:

  • Dr Cyrile Anne Curat

  • Ingrid Löhr-Kottmann


Workshop 3: Decentralised Clinical Trials

  • Dr Simona Berardi Vilei, Head GCP/GVP Inspectorate

  • Nicole Torti, GCP/GVP Inspector

  • Silvia Stüdeli, Clinical Study Assessor


Workshop 4: Quality & GMP – Special Aspects

Clinical Study Assessors:

  • Dr Verena Gafner

  • Dr Guy Lemaillet

14:45
Change of Workshop rooms & Coffee to take away
15:00
Workshops 2nd round


Workshops are carried out in parallel and each Workshop will be held twice. Therefore, you can participate in 2 different Workshops.


Workshop 1: Staying Connected, Staying Compliant – ICH GCP Requirements Related to the Use of Electronic Devices

GCP/GVP Inspectors:

  • Dr Ruth Hinrichs

  • Denis Mosimann


Workshop 2: From Findings to Fixes: Swissmedic Perspective on CAPA Plans

GCP/GVP Inspectors:

  • Dr Cyrile Anne Curat

  • Ingrid Löhr-Kottmann


Workshop 3: Decentralised Clinical Trials

  • Dr Simona Berardi Vilei, Head GCP/GVP Inspectorate

  • Nicole Torti, GCP/GVP Inspector

  • Silvia Stüdeli, Clinical Study Assessor


Workshop 4: Quality & GMP – Special Aspects

Clinical Study Assessors:

  • Dr Verena Gafner

  • Dr Guy Lemaillet

16:30
End of the Symposium


Registration

Venue

Welle7

Schanzenstrasse 5, Bern
3008 Bern

Contact

For questions, please contact the following address:

events@swissmedic.ch