EU CTR Reviewers in the Netherlands

Our EU CTR Reviewers in the Netherlands e-learning course gives you the essentials on the upcoming European Clinical Trial Regulation and everything you need to know to review submission dossiers according to the Dutch regulatory requirements. Includes 2 interactive modules, 1 test and takes 3.5 hours to complete.

 65.00

Additional information

Accreditation

, , , , , ,

Job Role

Language

,

Level

Phase of Study

Region of Regulation

Regulation

Need more than 5 licenses?

Connect with our corporate team to discuss your organization’s learning needs and discover how our training solutions can help transform your business.

Category: Tag:

LEARNING OBJECTIVES

  • Principles of EU CTR (EU Clinical Trial Regulation)
  • Critical timelines for submission and review of a dossier
  • Transition period and expected implementation
  • EU CTR (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

EU CTR 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 EU CTR regulation will affect everyone involved in clinical drug research in Europe and will help improve collaboration between all parties involved.

The EU CTR Reviewers in the Netherlands not only helps you understand the upcoming EU CTR 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 EU CTR certificate
  • incl. Knowledge test
  • Accredited by several quality registers
  • 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 EU CTR and its implications for the assessment process and is most suitable for employees of the CCMO and members of the Dutch ethics committees.

The online course takes 3 hours and consists of the basic EU CTR module, the submission module and a knowledge test. After completion, you will receive an online EU CTR certificate.

Enroll now to get started with the myGCP learning modules on your smartphone, tablet, or desktop computer.

 

COURSE CONTENTS

[toggles title=”Module:  Introduction”]
You’ll learn the following in this module:

  • The goal and high-level contents of the EU CTR
  • Scope of the EU CTR: to which type of research the EU CTR is applicable
  • Dutch ambition regarding the introduction of the EU CTR
  • Opportunities, benefits, and challenges of the EU CTR and submissions via the EU-portal (CTIS)
  • Information about the transitional period from CTD to EU CTR
  • Timelines of the submission- and review process according to the EU CTR 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

[/toggles]

[toggles title=”Module: Submission and review”]
You’ll learn the following in this module:

  • Process steps, communication, and the result of the validation process of Part I (national) and Part II (multinational)
  • Submission process via the EU-portal (CTIS)
  • Determination process which member state takes the role of Reporting Member State (rMS)
  • Considerations for answering questions during the review process and adjustments to the application dossier
  • Composition review committee
  • Review whether the clinical trial is included in the scope of the EU CTR
  • Review of completeness and acceptability of the clinical trial and application dossier
  • Consolidated and coordinated review
  • Getting to a conclusion and the requirements to the assessment report

[/toggles]

[toggles title=”Module: Knowledge test”]
The knowledge test includes:

  • 20 questions
  • Available in English and Dutch
  • Feedback per question (afterwards)
  • 3 attempts
  • Online certificate with a score of 80 or higher

[/toggles]

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.

Reviews

Be the first to review “EU CTR Reviewers in the Netherlands”

Do you know someone who would like this course? Tell them about it…