The implementation of the EU Clinical Trials Directive in May 2004 resulted in significant changes in the approval process and conduct of clinical trials in the EU. Further discussion culminated in the adoption in April 2014 of Regulation (EU) No 536/2014 on clinical trials on medicinal products for human use, and plans to repeal Directive 2001/20/EC.
This symposium will describe the changes that are to be introduced by the Regulation, how and when these changes will be implemented, and how this is likely to impact on the attractiveness of the EU for conducting clinical research. The programme will include a selection of speakers from the MHRA, industry and the NHS who are involved in approval or conduct of clinical trials. They will share their views on the likely impact of the revised legislation, and current best practice in their specific areas of practice.
This symposium will describe the changes that are to be introduced by the Regulation, how and when these changes will be implemented, and how this is likely to impact on the attractiveness of the EU for conducting clinical research. The programme will include a selection of speakers from the MHRA, industry and the NHS who are involved in approval or conduct of clinical trials. They will share their views on the likely impact of the revised legislation, and current best practice in their specific areas of practice.
