Regulatory aspects of clinical trial authorisation in - CGT

WORKSHOP ONCOLYTIC VIRUSES
Regulatory aspects of clinical trial authorisation in
Germany - challenges and opportunities
Thursday, June 25, 2015
9:00 – 15:30
Hörsaal, Paul-Ehrlich-Institut, Langen
In collaboration with the German Cancer Consortium DKTK
Contact: [email protected]
This multi-stakeholder workshop addresses the regulatory aspects of authorizing
clinical trials with Oncolytic Viruses in Germany and provides a platform to discuss
challenges, expectations and opportunities.
9:00-9:30
9:30
9:40-10:40
9:40
10:20
10:40-10:50
Registration and welcome coffee
Welcome and opening remarks
Klaus Cichutek, Michael Mühlebach, Martina Schüßler-Lenz,
Paul-Ehrlich-Institut
Session 1: Where do we stand –clinical and regulatory aspects
Chair Ulrich Lauer, Tübingen
Clinical aspects
The academic view
Guy Ungerechts, Heidelberg, Ulrich Lauer, Tübingen
The industry view
Ulrike Schulte, AMGEN
NN, TRANSGENE
Regulatory aspects
Martina Schüßler-Lenz, Paul-Ehrlich-Institut
Discussion
German Cancer Consortium
Federal Institute for Vaccines and Biomedicines
10:50:-12:10
10:50
11:10
11:30
11:50
Session 2: Approval of clinical trials with oncolytic viruses procedural aspects
Chair Matthias Schweizer, Paul-Ehrlich-Institut
The Clinical Trial Authorisation process for oncolytic viruses in Germany present and future
Hartmut Krafft, Paul-Ehrlich-Institut
The Environmental Risk Assessment of genetically modified organisms
(GMOs) used in clinical trials
Brigitte Anliker, Paul-Ehrlich-Institut
The Clinical Trial Authorisation process for oncolytic viruses in France
Nicolas Ferry, ANSM, France
The process in the hospital – experience of a hospital pharmacist
NN
12:10-12:20
Discussion
12:20-13:20
Lunch Foyer in front of conference hall
13:20-14:00
Session 3: Safety monitoring, shedding and transmission to third
parties
Chair Zoltan Ivics, Paul-Ehrlich-Institut
Clinical experience with patients treated with oncolytic viruses
Silvia Gross, Tübingen
Risk assessment during pharmaceutical and clinical development of
vaccines for human use.
Michael Pfleiderer, Paul-Ehrlich-Institut
Panel discussion
Moderated by Klaus Cichutek
Paul-Ehrlich-Institut, Bundesamt für Verbraucherschutz und
Lebensmittelsicherheit (BVL), Landesbehörden, clinicians, industry, patient
representative.
13:20
13:40
14:10 – 15:30
15:30
Questions may be submitted prior to the workshop to
[email protected]
Closing remarks
Michael Mühlebach, Martina Schüßler-Lenz, Paul-Ehrlich-Institut
German Cancer Consortium
Federal Institute for Vaccines and Biomedicines

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