LEARNING OBJECTIVES
- 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
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 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
- Accreditated by several quality registers
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.
Published –
A perfect way to learn and understand the complexity of ECTR, but also to receive the knowledge and toolset needed.