- 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 and responsibilities for the Pharmacist and Pharmacy Assistant in the preparation and conduct of clinical drug research
- Documentation requirements for the 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
Pharmacists and pharmacy assistants who are involved in the management and handling of trial medication for clinical drug research learn about the basics of the applicable regulations in this course. It is the ideal introduction to the international Good Clinical Practice (GCP) guideline and the Dutch Medical Research Involving Human Subjects Act (WMO).
In this interactive basic GCP course for the Pharmacy, participants will be taught all there is to know about IMP, logistics in the Pharmacy, and the process of receiving, handling, distributing, and return of the IMP via recognizable case scenarios.
All of our training courses come with a full one-year license of continuous learning so you can stay up-to-date with changing regulations and guidelines.
After you’ve completed your course, you’ll earn your crucial GCP Certificate.
Enroll now to get started with the myGCP learning modules on your smartphone, tablet, or desktop computer.
- Ethics – Declaration of Helsinki
- Regulations: ICH-GCP, EU Directives, Clinical Trial Regulation, the GMP Guideline, and WMO
- Responsibilities of Sponsor, CRO, investigator, Research Nurse, Pharmacist, and Pharmacy Assistant
- Documentation requirements for IMP information: Investigator’s Brochure (IB), Protocol and Investigational Medicinal Product Dossier (IMPD)
- Quality (control) of IMP
- Standardization of work activities (Standard Operating Procedures)
- Essential documents – Archiving
- Audit/inspection readiness
- Discuss case scenarios of participants and answer questions