Swissmedic Symposium Clinical Trials


Monday, 4 November 2024

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.

In order to tailor the presentations/workshops to your needs, you do have the possibility to send us questions related to the agenda items prior to the symposium.

Interested? Then please register using the registration form and let us know your questions. The registration deadline is 1 October 2024.


Participation

Participation at this symposium is per invitation only. 1 to 2 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").

A participation fee of CHF 200.00 + 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 200.00 + VAT

  • Registration deadline: 01.10.2024 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
08:45
Registration and welcome coffee
09:15
Opening and Introduction

Dr Simone Ferbitz

Head of Division Clinical Trials

09:30
Revision of the Clinical Trials Ordinance and its implication for clinical trial submissions

Dr Verena Gafner

Senior Clinical Study Assessor

10:00
Major changes ICH GCP E6 R3 / Ongoing safety evaluation

Dr Reto Iannaccone

GCP/GVP Inspector


Dr Mario Baresic

GCP/GVP Inspector

11:00
Coffee break & Networking
11:30
Fee reduction for non-commercially funded clinical trials

Dr Simone Ferbitz

Head of Division Clinical Trials

11:45
Source data handling and location

Dr Cyrile-Anne Curat

GCP/GVP Inspector

12:15
Customs Project

Dr Mario Baresic

GCP/GVP Inspector

12:30
Lunch Break & Networking
13:30
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: Sponsor oversight


GCP/GVP Inspectors:

  • Ingrid Löhr Kottmann

  • Adisa Cokoja

  • Denis Mosimann



Workshop 2: Inspection findings


GCP/GVP Inspectors:

  • Isabelle Meienberger

  • Dr Simona Berardi Vilei

  • Dr Ruth Hinrichs



Workshop 3: Revision of the Clinical Trials Ordinance and its implication for clinical trial submissions


Clinical Study Assessors:

  • Dr Catherine Berset Kipouros

  • Dr Verena Gafner

  • PD Dr Rolf Kaiser

  • Silvia Stüdeli



Workshop 4: Frequent Deficiencies in CTA/Amendment Submissions


Clinical Study Assessors:

  • Dr Mayra Latorre Martinez

  • Dr Guy Lemaillet

  • Dr Carmen Campanile

  • Patricia Plattner

  • Dr Caroline Lämmli

  • PD Dr Thomas Schochat

15:00
Change of workshop rooms & Coffee to take away
15:15
Workshops 2nd round


Workshop 1: Sponsor oversight


GCP/GVP Inspectors:

  • Ingrid Löhr Kottmann

  • Adisa Cokoja

  • Denis Mosimann



Workshop 2: Inspection findings


GCP/GVP Inspectors:

  • Isabelle Meienberger

  • Dr Simona Berardi Vilei

  • Dr Ruth Hinrichs



Workshop 3: Revision of the Clinical Trials Ordinance and its implication for clinical trial submissions


Clinical Study Assessors:

  • Dr Catherine Berset Kipouros

  • Dr Verena Gafner

  • PD Dr Rolf Kaiser

  • Silvia Stüdeli



Workshop 4: Frequent Deficiencies in CTA/Amendment Submissions


Clinical Study Assessors:

  • Dr Mayra Latorre Martinez

  • Dr Guy Lemaillet

  • Dr Carmen Campanile

  • Patricia Plattner

  • Dr Caroline Lämmli

  • PD Dr Thomas Schochat

16:45
End of the Symposium


Registration

Venue

Welle7

Schanzenstrasse 5, Bern
3008 Bern

Contact

For questions, please contact the following address:

events@swissmedic.ch