Good Clinical Practice (GCP)
After course completion, attendees will have developed a basic understanding of GCP requirements for the planning, preparation, and conduct of clinical trials with medicinal products. Thus, based on their individual background, attendees should also be able to identify potential occupational fields in the industry dealing with GCP topics.
Successful participation will be certified by the Gläsernes Labor Akademie (GLA).
- History and development of GCP
- differentiation between clinical trial and non-interventional study
- responsibilities of study sponsors including risk-based approach, quality management (quality assurance and quality control); responsibilities of the investigator in practical terms
- submission to ethics committees and competent authoritie
- preparation, conduct, and reporting of a clinical trial with medicinal products.
The course is directed:
- to staff from pharmaceutical or biotech companies starting or planning to start clinical development programs having no or little experience with the current GCP requirements,
- to natural scientists, PhD students and Postdocs of natural scientific and medical degree programs who are interested in getting an overview on GCP