- Principles of ECTR (EU Clinical Trial Regulation)
- Critical timelines for submission and review of a dossier
- Transition period and expected implementation
- Impact on the conduct of a clinical drug trial in Europe
- Understand the changes and be prepared for its implementation in 2021
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 Introductory ECTR course for clinical trials in Europe explains the principles of the new regulation, clarifies the critical timelines, helps you understand the changes, and be prepared for its implementation in 2021. Be ECTR ready.
- 1.5 hours
- 1 Learning Module
- Online ECTR certificate
- Knowledge Test
- Available on desktop, smartphone, or tablet
- Accreditation pending
It is an ideal introductory course suitable for anyone (clinical and non-clinical) involved or interested in medical science and drug research. The course enables you to get a good overview of the new regulations and the consequences of the implementation of clinical drug research. It is perfect for: doctors, research nurses, patients, students (medicine or biology), clinical trial assistants, employees of CROs, employees of (hospital) pharmacies. The online course takes 1.5 hours and consists of the basic ECTR module and a knowledge test. After completion, you will receive an online ECTR certificate.
- Goal ECTR and difference between a Directive and Regulation
- Scope of ECTR: to which type of research is the ECTR applicable?
- High-level contents of the ECTR
- Opportunities, benefits, and challenges of the ECTR and submissions via the CTIS portal
- When will the ECTR be implemented and what does the transition period look like?
- Timelines of the submission- and review process according to the ECTR regulation
- Differences in the submission of a national trial and an international trial
- Results of the validation phase, Assessment part I and assessment part II
- Differences in the submission of investigator-initiated trials and sponsor (pharma/biotech) initiated trials
The knowledge test includes:
- 10 questions
- Available in English and Dutch
- Feedback per question (afterwards)
- 3 attempts
- Online certificate with a score of 80 or higher