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Expert WMO GCP Training for the Pharmacy

The (virtual) Expert GCP course for pharmacists and pharmacy assistants builds upon the current knowledge of Good Clinical Practice and WMO derived during the Basic GCP Training for the Pharmacy. It is a practical course with a focus on exchanging experiences and solving case scenarios. This live (virtual) training is either provided in our training facility in Amsterdam (1 day of 6 hours) or via 2 virtual online* meetings of 3 hours. *In case of restrictions for live meetings due to Corona.

€ 299.00

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LEARNING OBJECTIVES

  • Updating your knowledge regarding the principles of ICH GCP and the ICH GCP Addendum R2
  • EU Directives 2001 & 2005 and the European Clinical Trial Regulation (ECTR)
  • Dutch legislation: Medical Research Involving Human Subjects Act (WMO)
  • Ethical principles for research and the Declaration of Helsinki
  • Roles, responsibilities, and expectations for the Pharmacist and Pharmacy Assistant in the preparation and conduct of clinical drug research
  • Discuss case scenarios and experiences with peers and the trainer
  • Documentation requirements for receiving, distribution, handling, use, and return of the IMP
  • The impact of the implementation of the Clinical Trial Regulation for the conduct of clinical drug research in the Netherlands
  • How to collaborate optimally with the investigator and research team?
  • What to expect from a monitor and how to ensure you are audit and inspection ready?

 

DESCRIPTION

Pharmacists and pharmacy assistants who before attended the Basic WMO GCP training for the Pharmacy or attended an Expert WMO GCP training for the Pharmacy more than 3 years ago can update their knowledge via this Expert training. In this highly interactive session, the updates on applicable regulations and guidelines are discussed. What are the updates and changes in the Good Clinical Practice Addendum R2? And what will be the impact of the implementation of the Clinical Trial Regulation (ECTR) in 2021?

Based on case scenarios, the requirements for the acceptance, handling, management, and distribution of IMPs are discussed. In this highly interactive training, and experiences Pharmacist and a Regulatory expert will answer your questions and challenge your knowledge.

 

COURSE CONTENTS

Program

You’ll learn the following in this module:

  • The updated ICH-GCP Guideline: changes and additions in the R2 Addendum
  • Recent changes to laws and regulation clinical research the Netherlands (WMO)
  • Responsibilities and expectations of Sponsor, CRO, investigator, Research Nurse, Pharmacist, and Pharmacy Assistant
  • How to collaborate optimally with the investigator and research team?
  • What to expect from a monitor and how to ensure you are audit and inspection ready?
  • Discuss expert case scenarios with an experienced Pharmacist
  • Audit/inspection readiness
  • Interactively exchange experiences and discuss case scenarios with the other participants

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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.

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