GCP-Trainings for Sponsors and CROs
Our team of experts has access to a well-founded level of experience in ICH GCP, CTR and the German “Arzneimittelgesetz” (AMG), built up in the Sponsor and CRO role. This knowledge is bundled into a one-day long training course, providing an overview about the general European and the specific German regulatory environ-ment. Theoretical requirements are illustrated by practical field examples. Course material can be flexible adapted to the audience’s area of interest.
Good Clinical Practice (GCP) is an international ethical and scientific quality standard for the design, conduct, recording, and reporting of clinical trials involving human subjects. It provides a framework to ensure that clinical trials are conducted to the highest ethical and scientific standards, and that the rights, safety, and well-being of trial subjects are protected. Compliance with GCP is demanded by Regulation (EU) 536/2014 Clinical Trials Regulation (CTR). National legal supplement to CTR in Germany is the “Arzneimittelgesetz” (AMG).
The training is structured by following the regulations gradually through each section. Knowing the regulations not only
from content, but from structure, will raise staffs’ efficiency upon using the regulations in their daily work.
Legal basis is outlined and put in contexts of its historic foundations. Interfaces between GCP, CTR and AMG are ex-plained.
GCP is trained in-depth. The responsibilities of the investigators and sponsor are emphasized. Investigator
responsibilities are put in context of common findings on-site. Throughout the GCP training, excursions to prominent
historic non-compliances are taken (e.g.Tuskegee study).
Relevant changes from CTR towards its national predecessor regulation, the German “GCP-Verordnung”, are highlighted. Clinical Trial Application System (CTIS) is explained. Application process is wrapped-up.
Focus is put on the AMG sections relevant to a Clinical Trial’s conduct: section 1, 6 and 11. In context of these, an overview
about the regulatory authorities in Germany is provided.
Additional content can be prepared according to the needs of the audience. Such can be, but is not limited to: practical workshop elements, basic medical device training (MDR, ISO 14155), computerized systems validation (GAMP 5), expected GCP changes, requirements towards electronic signatures (eIDAS), etc.