FROM VOLUNTARY HARMONISATION TO CLINICAL TRIAL REGULATION L TRIALS

Track:
Legal/Transparency-Risk Assessment

Day & Time:
March 6, 9:00AM - 10:30AM

Session Number:
0305

Room Number:
G103

Type:
Session

Title:
FROM VOLUNTARY HARMONISATION TO CLINICAL TRIAL REGULATION L TRIALS

Chair(s):
Hartmut - Krafft, PhD,MSc
Head, Clinical Trials Unit
Paul-Ehrlich-Institut, Germany

Description:
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.

Presentation(s) & Speaker(s):
Introduction- Voluntary Harmonisation Procedure
Hartmut - Krafft, PhD,MSc
Head, Clinical Trials Unit
Paul-Ehrlich-Institut, Germany

The New Clinical Regulation – EFPIA position
Sabine Atzor, RPh
Head of EU Regulatory Policies
F. Hoffmann-La Roche Ltd, Switzerland

The New Clinical Trial Regulation – challenges in the implementation of the new system
Anna Hallersten, MSc
Public Affairs Director
SFL Regulatory Affairs & Scientific Communication Ltd, Switzerland