The seminar will include presentations with a lot of practical examples as well as workshops on the most important topics of GCP. The trainer will focus on the responsibilities of the study sponsor (e.g. pharmaceutical or biotech company) but will also cover those elements that are of importance for the investigational team at the study site, i.e. at the hospital or private practice.
According to local law (§ 11 Berliner Bildungsurlaubsgesetzes BiUrlG) educational leave applies.
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 authorities; preparation, conduct and reporting of a clinical trial with medicinal products.
The qualification will comprise a total of 8 lessons which will be held on Thursday, 06 Jun 19 from 9:00 a.m. till 05.00 p.m.
The course will be held with a minimum of 6 and a maximum of 16 attendees. Due to organizational reasons, an early registration is recommended.
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 being interested in getting an overview on 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, also participating academic researchers should be able to identify potential occupational fields in the industry dealing with GCP topics.
The successful participation will be certified by the Gläsernes Labor Akademie (GLA).