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International CTFG Workshop on the Voluntary Harmonization Procedure (VHP) for the Assessment of Multinational Clinical Trial Applications, 30 April 2010, Bonn

Post Meeting Addendum:
We received positive feedback on the VHP meeting from all concerned parties. The various experiences presented and the active discussion on the new guidance document were greatly appreciated by the participants.
For this we wish to express our sincere thanks to all who contributed to the success of the meeting.
We are looking forward to sharing further VHP assessments with you.
Below you will find links to presentations given at the workshop.

On behalf of the Clinical Trial Facilitation Group (CTFG) of the Heads of Medicines Agencies (HMA) the German Federal Institute for Drugs and Medical Devices (BfArM) would like to invite sponsors of European multinational clinical trials to the “CTFG Workshop on the Voluntary Harmonisation Procedure (VHP) for the Assessment of Multinational Clinical Trial Applications”. The workshop will be held on 30 April 2010 at the BfArM in Bonn in collaboration with the Paul-Ehrlich-Institute (PEI).

An introduction into the VHP will be given presenting the experiences made by commercial and non-commercial sponsors as well as by competent authorities. The meeting will then focus on possible further improvements of the VHP. For details please refer to the

and the . Participation will be free of charge. Unfortunately, the BfArM is not able to reimburse any travel expenses.

For details on the new VHP guidance please refer to the PEI website Voluntary Harmonisation Procedure for multinational clinical trials in Europe (VHP)

If you are interested in participating at this workshop, please contact Dr Elke Stahl (

Looking forward to welcoming you to Bonn!