This webinar will review the changes introduced by the new European Union ('EU') Clinical Trials Regulation and the implications for future clinical trials.
This Regulation imposes new obligations on clinical trial sponsors, including increased disclosure obligations related to trial results. However, it also introduces new opportunities, such as the possibility for trial participants to extend their informed consent to include future scientific review of the trial results.
This webinar will analyze the new obligations on trial sponsors and the new opportunities introduced by the Regulation. It will help attendees to prepare for the changes introduced by the new Regulation.
Why Should You Attend:
The new European Union ('EU') Clinical Trials Regulation was adopted on April 15, 2014. The Regulation will enter into effect at latest two years following its publication in the Official Journal of the European Union. The Regulation, which will replace the existing Clinical Trials Directive, introduces a complete overhaul of the existing regulation of clinical trials for medicinal products in the EU.This Regulation imposes new obligations on clinical trial sponsors, including increased disclosure obligations related to trial results. However, it also introduces new opportunities, such as the possibility for trial participants to extend their informed consent to include future scientific review of the trial results.
This webinar will analyze the new obligations on trial sponsors and the new opportunities introduced by the Regulation. It will help attendees to prepare for the changes introduced by the new Regulation.
Areas Covered in the Webinar:
- New authorization procedure for clinical trials
- Extension of clinical trials to other EU Member States
- Increased disclosure obligations
- New reporting requirements
- Extending informed consent for future uses
- Indemnity and insurance
- Co-sponsorship
Who Will Benefit:
This webinar will provide guidance to those involved in the field of clinical research in the EU, particularly sponsors of clinical trials. In addition, the webinar will help regulatory compliance officers and managers in ensuring compliance with the new requirements of the clinical trials regulation.- Sponsors and non-commercial sponsors
- Consultants
- Laboratories analyzing samples from clinical trials
- Regulatory affairs
- Clinical trial supply
- Clinical development managers and personnel
- Clinical operations
- Clinical research associates
- Clinical research archiving and document management personnel
- Quality assurance managers and auditors
- Clinical development managers and personnel
- CROs using laboratories to analyze clinical trial samples
- Project management
Course Provider
Ciara Farrell,
