(1 customer review)

Re-Certification WMO GCP Course for Clinical Trials in the Netherlands

This course was previously called “WMO-GCP Re-certification”. The online GCP re-certification course is applicable to researchers and research staff registered in the Dutch GCP-WMO register (EMWO) who need re-certification after 3 years of being registered. Includes 7 interactive modules.

 125.00

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LEARNING OBJECTIVES

  • Principles of ICH GCP and the ICH GCP Addendum R2
  • EU Directives 2001 & 2005 and the European Clinical Trial Regulation (ECTR)
  • Update to the Medical Research Involving Human Subjects Act (WMO)
  • EU Privacy regulation (GDPR)
  • Research with medical devices
  • Safety reporting for drug and medical device research
  • Publication of research results, FAIR data principles
  • Insurance for subjects
  • Requirements for research with minors
  • Monitoring, auditing, and inspections

 

DESCRIPTION

Are you registered in the Dutch GCP-WMO register and is your registration about to expire? Successful completion of the Re-certification WMO GCP course for Clinical Trials in the Netherlands extends your registration in the GCP-WMO register with 3 years.

This online Re-certification WMO GCP course is suitable for experienced researchers and research staff who are registered in the GCP-WMO register, managed by EMWO.

In this course, you will learn about all changes in the applicable legislation, including Medical Research Involving Human Subjects Act (WMO), the EU Clinical Trial Regulation, ICH GCP Addendum R2, and the GDPR Privacy legislation. The course also explains the requirements for research with medical devices, quality assurance, and risk management, scientific integrity, multicenter research.

After your successful completion of the course, we will inform EMWO who will extend your registration in the GCP-WMO register with 3 years. You will receive notification from EMWO when this has happened.

PLEASE NOTE. Check if you are registered in the GCP-WMO register. This course is only applicable for researchers and research staff who have an active registration in the GCP-WMO register. In case your registration has expired, or if you are not registered, we recommend to take the Expert Course to WMO GCP Course to Clinical Trials in the Netherlands

 

COURSE CONTENTS

Module 1: Introduction
Module 2: Design
Module 3: Preparation
Module 4: Submission
Module 5: Start
Module 6: Conduct
Module 7: Archiving (Close-out)

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 Re-Certification WMO GCP Course for Clinical Trials in the Netherlands

  1. Published

    Very practical and to the point training. Quick and superficial if you want, but enough click-through material if need in-depth training

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