The Clinical Trials Workshop 2015 is dedicated to implementation of the new Clinical Trial Regulation in 2016.
The Clinical Trials Workshop 2015 covers topics such as:
- 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
The Clinical Trials Workshop 2015 brings together:
- 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
