Clinical Trials Workshop

This 2-day workshop will provide a forum for information exchange and discussion on conceptual and practical questions through lectures and panel discussions.There will be a particular focus on the critical issues affecting sponsors and Member States as they consider the impact and changes needed to implement the regulation.

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Session 2 Considerations by Member States as they work towards Implementation of the Regulation

Session Chair(s)

Clare Lavery, MSc

Pharmacovigilance Excellence Principal

AstraZeneca, United Kingdom

Nick Sykes, MS

Policy Advisor

EFPIA, Belgium

The different Member States (MS) will be asked for their views on what they consider to be the key challenges for implementation of the CTReg including: - A perspective on how MS are ensuring interaction and co-operation between competent authorities and ethics committees - How MS will ensure a co-ordinated assessment within the timelines - Where and how MS have been involved in pan-EU efforts for implementation - Current application of VHP to pilot some of the new processes - MS plans for involvement of the patient in clinical trial decision-making