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FROM VOLUNTARY HARMONISATION TO CLINICAL TRIAL REGULATION L TRIALS
Session Chair(s)
Hartmut Krafft, PhD, MSc
Head, Clinical Trials Unit
Paul-Ehrlich-Institut, Germany
Experience in the implementation of the Clinical Trial Directive 2001/20/EC has differed. This was the reason for the European Commission to review and reorganise the monitoring system for clinical trials in the EU. After hearing stakeholders, a draft of an EU Regulation is now published. In particular “Pan European Studies“ call for a consistent set of regulations. Otherwise, the studies run the risk of failing due to the different requirements in the individual Member States. The session will show whether the European Commission developed a new concept that meets the requirements for a successful Pan-European-Research.
Speaker(s)
Introduction- Voluntary Harmonisation Procedure
Hartmut Krafft, PhD, MSc
Paul-Ehrlich-Institut, Germany
Head, Clinical Trials Unit
The New Clinical Regulation – EFPIA position
Sabine Atzor, MPharm, RPh
F. Hoffmann-La Roche Ltd, Switzerland
Head of EU Regulatory Policies
The New Clinical Trial Regulation – challenges in the implementation of the new system
Anna Hallersten, MSc
Roche Diagnostics, Switzerland
Head Regulatory Policy Europe
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