(2 customer reviews)

Expert Blended WMO GCP Course for Clinical Trials in the Netherlands

This course was previously called “Blended WMO-GCP training”. In this mix of self-paced e-learning and a live online training, you will learn everything you need to know to master ICH-GCP and the WMO law applicable to clinical trials in the Netherlands. Includes 7 interactive e-learning modules and 3 live online training sessions of 3 hours. For individual registrations.

 425.00

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LEARNING OBJECTIVE

  • ICH GCP and ICH GCP R2 Addendum
  • EU Directives (2001 and 2005)
  • Dutch legislation: Medical Research Involving Human Subjects Act (WMO), WGBO, and Wet BIG
  • Roles in clinical research
  • Privacy in clinical research (GDPR)
  • Informing research participants
  • Essential documents
  • Review by the Ethics Committee
  • Safety reports and safety of your subjects, incl. AEs, SAEs, and SUSARs
  • Quality management
  • Amendments and derogations
  • Final report
  • Audits and inspections

 

DESCRIPTION

The expert blended GCP course for clinical research in the Netherlands is the optimal mix: learn about GCP guidelines and Dutch legislation (WMO) online, at your own pace, and apply the GCP rules to practical situations in an instructor-led (virtual) classroom session at our training facility in Amsterdam.

This training is the optimal preparation for the WMO/GCP exam organized by EMWO, which leads to registration in the WMO/GCP register. The self-paced online course gives you a practical understanding of the ICH GCP guidelines and Dutch legislation (WMO) in a logical order: from design to the close out of clinical trials.

After completion of the 7 modules of the online course, you have the knowledge to have in-depth discussions at the (virtual) classroom session. The program of the classroom session is tailored to the needs of the attendees and allows maximum interaction. You are challenged to apply your GCP knowledge to solve practical case studies. You will exchange knowledge and experiences with peers and have in-depth discussions with the trainer to maximize your learning experience.

This course is ideal for starters in the clinical research industry in the Netherlands and experienced staff looking for an extensive update on ICH GCP and Dutch legislation (WMO).

The completion of the training takes 17 hours, including 8 hours of online learning and 3 virtual* classroom session of 3 hours. (*We provide virtual classroom training due to corona restrictions)

After you have completed all components of the blended GCP course for Clinical Trials in the Netherlands, you will receive a WMO/GCP Certificate, recognized by Transcelerate and accredited by several quality registers.

All training courses include one-year access to your online training. With our continuous learning model, we will keep you up-to-date with changing regulations and guidelines.

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

 

COURSE CONTENTS

Module 1: Introduction
Module 2: Design
Module 3: Preparation
Module 4: Submission
Module 5: Start
Module 6: Conduct
Module 7: Archive (Close-out)
Module 8: (Virtual) classroom session

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.

2 reviews for Expert Blended WMO GCP Course for Clinical Trials in the Netherlands

  1. Published

    Equipped me with the necessary skills and mindset.

  2. Published

    Excellent. I was able to learn at my own pace and I will put into practice a lot of things learned during the course. Very different and great experience of learning. Simple yet powerful and influential environment for learners.

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