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Clinical Trials Workshop
Are we ready for implementation of the new Clinical Trials Regulation?

The new EU Clinical Trials Regulation is expected to become applicable in 2016. The new legislation will have implications on clinical trial sponsors preparing and submitting clinical trial applications. Member States will have to adapt their procedures for the assessment of clinical trial applications by competent authorities and review by ethics committees. Additionally, the new Regulation will impact how the conduct of a clinical trial is managed after approval has been granted. New provisions for public access to an EU Clinical Trials Database will enforce disclosure of clinical trials data and information.

Download Programme

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. 

Featured topics

Key aspects of and differences between the present and new requirements on managing clinical trials including:  

  • Member States preparedness for the Regulation, including plans for co-operation between agencies and ethics committees and coordinated assessment
  • Considerations for the preparation of applications and notifications by sponsors
  • Role of the European Commission and proposals for implementing measures
  • EMA Status report - development of the EU clinical trials portal and database
  • Impact of new requirements for disclosure and transparency of data from clinical trials

Who should attend?

This workshop is aimed at intermediate and experienced professionals from

  • Regulatory agencies
  • The pharmaceutical industry and contract research organisations including:
    • Staff from clinical science and clinical operations
    • Monitors, auditors of clinical trials
    • Regulatory affairs personnel
    • Pharmacovigilance staff

Program Committee

  • Clare  Lavery, MSc
    Clare Lavery, MSc Pharmacovigilance Excellence Principal
    AstraZeneca, United Kingdom
  • Nick  Sykes, MS
    Nick Sykes, MS Director, European Regulatory Policy
    Pfizer Ltd., United Kingdom
  • Sabine  Atzor, RPh
    Sabine Atzor, RPh Director Regulatory Affairs , EFPIA, Belgium
    On Secondment From F. Hoffmann-La Roche, Switzerland
  • Elke  Stahl, PhD
    Elke Stahl, PhD CTFG co-chair; Clinical Trial Unit
    Federal Institute For Drugs and Medical Devices (BfArM), Germany
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Contact us

Registration Questions

Send Email
+41 61 225 51 51

Agenda and Logistics Questions

Send Email
+41 61 225 51 49

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