The European Clinical Trial Regulation 536/2014, of April 2014, is to become the mandatory unique rule governing clinical trials in Europe. You need to understand the new requirements and major changes compared with the current legislation, but you have no time to read the full version of the European Clinical Trial Regulation 536/2014?
For this 1.5-hour interactive webinar, we apply the “less is more” principle with schematic presentations helping you to get a crystal-clear view of the changing legislative landscape in order to prepare you and your organisation for a smooth transition. The regulation will have no more surprises to you.
You will learn about scope, definitions, application and validation processes, mandatory notifications, rules for safety reporting, timelines and time table for implementation of the European Clinical Trial Regulation 536/2014. This webinar is your “rough guide” to grasp the main rules prior to its implementation. In addition, you will have the opportunity to ask questions during and after the session. The session ends with an extensive Q&A round.
The webinar will allow participants to attend from all over the world, without any travel requirements.
Course timeWebinar 1.5h from 16h00 to 17h30
Who should attend
Everyone involved in clinical research including: staff of pharmaceutical companies, contract research organisations (CROs), investigators, site personnel and ethics committee members. People from clinical research, regulatory affairs and pharmacovigilance departments within the pharmaceutical industry.
- Framework of the current and future European Clinical Trial Legislation
- The European Clinical Trial Regulation 536/2014:
- New definitions
- Clinical Trial Application Process
- Mandatory Notifications
- Safety Reporting
- Time Table for Implementation
- Grasp the main processes and requirements of the European Clinical Trial Regulation 536/2014.
- Understand what is needed to come to implementation of the Regulation
This course covers competencies that are part of the ECCRT Competency Framework
- Scientific Concepts & Research Design (0)
- Ethical & Participants Safety Considerations (1)
- Investigational Product Development and Regulation (3)
- Clinical Studies Operations (GCPs or ISO 14155) (2)
- Study and Site Management (0)
- Data Management and Informatics (1)
- Leadership and Professionalism (0)
- Communication (0)
- Teamwork (0)
- Business acumen (0)
Be aware that attending one of ECCRT open course does not guarantee that the competency is acquired but only guarantees that the related knowledge has been trained