With the constant increase of our e-learner base, we think of ways to accommodate your different learning and compliance needs. This is why we recently launched our new Refresher ICH GCP Course for Clinical Drug Trials in Germany.
Our Refresher ICH GCP Course is designed for study nurses and members of an investigational team who need to refresh their knowledge of the German Medicines Act (AMG) applicable to clinical drug research with human subjects (Arzneimittelstudien). It is compliant with the requirements of the German Medical Association (Bundesärztekammer).
What will you learn?
With the Refresher ICH GCP Course for Clinical Drug Trials in Germany, you update your knowledge of the Sponsor and Investigator responsibilities for clinical trials with medicinal products in Germany.
You’ll specifically dive into:
- the legal basis for clinical trials with medicinal products in Germany (ethical basics, definitions and scope)
- upcoming changes in German and European legislation (VO (EU) 536/2014)
- roles and responsibilities of the sponsor and investigator in the planning and preparation of the clinical study
- the study implementation in the test center (patient inclusion, education, study implementation in accordance with the protocol, documentation, adverse events, monitoring, amendments)
How does the german ich gcp course look like?
This highly interactive and self-paced online refresher course offers you the opportunity to take the e-learning training on your smartphone, tablet or PC, whenever and wherever you want.
It consists of 4 online training modules that are divided into chapters of 10 to 40 minutes, representing a total workload of 3,5- 4 hours.
You can choose to take the course in German or English.
After you have completed all components of the Refresher ICH GCP Course for Clinical Drug Trials in Germany and succeeded in the final knowledge test, you will receive a GCP Certificate. This certificate is accredited by the Ärztekammer Schleswig-Holstein and complies with the requirements of the German Medical Association.
TAKE THE NEXT STEP
Learn everything you need to know to refresh your ICH GCP knowledge for clinical drug trials in Germany via this highly interactive, self-paced, and certified e-learning course.