Clinical Trials Workshop 2015

The Clinical Trials Workshop 2015 is dedicated to implementation of the new Clinical Trial Regulation in 2016.

Topics

• Role of the European Commission and proposals for implementing measures
• 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
• Impact of new requirements for disclosure and transparency of data from clinical trials
• EMA Status report - development of the EU clinical trials portal and database

Who should Attend

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