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Fundamental ECTR Course to Review Clinical Drug Trials in Europe

This course was previously called “ECTR Reviewers – NL”. Our Fundamental ECTR e-learning course gives you the essentials on the upcoming European Clinical Trial Regulation and everything you need to know to review submission dossiers. Includes 2 interactive modules, 1 test, and takes 3.5 hours to complete.

 65.00

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Region of Regulation

Regulation

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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.

 

COURSE CONTENTS

Module 1: Introduction
Module 2: Submission and review

Learn anytime, anywhere

Learn at your own pace on your smartphone, tablet or desktop. You will have one year of access to the training and resources so you can look up information even after you’ve completed the course.

Learn Continiously

Continuous Learning can both improve clinical research quality and ensure a motivated research team. You’ll benefit from better knowledge retention and reduced risks. We When a regulatory update is announced, we update the training modules and notify you, so that you can take the updated module and earn a new GCP certificate.

Earn your gcp certificate

With our courses, you can earn and maintain your vital industry-recognized certificate. In your GCP Passport, you can now see exactly which version of a training module you were most recently trained on. This documentation in combination with the changelog will inform auditors, managers, and inspectors of the associate’s compliance with current regulations.

1 review for Fundamental ECTR Course to Review Clinical Drug Trials in Europe

  1. Published

    This course gave me wonderful training

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