LEARNING OBJECTIVES
- Principles of ECTR (EU Clinical Trial Regulation)
- Critical timelines for submission and review of a dossier
- Transition period and expected implementation
- ECTR (EU Clinical Trial Regulation)
- Role of the reviewer, collaboration with other member states and submitters
- Review requirements and use of CTIS portal
- Deadlines and planning of the medical-ethical review
- How to address questions at the submitter of the dossiers
DESCRIPTION
ECTR stands for European Clinical Trial Regulation. This is the new EU regulation on clinical trials of medicinal products for human use which replaces the existing Directive 2001/20/EC. The ECTR regulation will affect everyone involved in clinical drug research in Europe and will help improve collaboration between all parties involved.
The fundamental ECTR course to review clinical trials in Europe not only helps you understand the upcoming ECTR regulation but offers a clear and in-depth understanding of the critical roles, deadlines, and planning of the new procedures for the medical-ethical review of a drug trial according to the new EU legislation. It will prepare you for its implementation in 2021.
- 3 hours
- 2 modules
- Online certificate
- incl. Knowledge Test
- Available on desktop, smartphone or tablet
It is an ideal course suitable for anyone involved in ethics committees or responsible for reviewing submitted clinical research dossiers. The course provides a detailed understanding of the ECTR and its implications for the assessment process and is most suitable for employees of the competent authorities of European member states and members of ethical committees.
The online course takes 3 hours and consists of the basic ECTR module, the submission module, and a knowledge test. After completion, you will receive an online ECTR certificate.
Enroll now to get started with the myGCP learning modules on your smartphone, tablet, or desktop computer.
Published –
This course gave me wonderful training