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.

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

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