Course on Good Clinical Practice

Graduiertenakademie
Symbolbild Forschung (Laborsituation)

Good Clinical Practice (GCP) is an international regulatory framework initially developed to facilitate drug development. The idea was that a commonly and internationally accepted standard would considerably help to generate comparable data with high quality worldwide and to accept drug trial data in countries and regions of the world where these trials have not been conducted.

Today, adherence to GCP is not only critical in drug development studies but the GCP principles have been widely adopted in other research fields involving humans as well.

We will present and discuss
- the general principles of clinical research ethics
- the regulatory framework for clinical trials involving drugs and medical devices in Europe
- principles and details of the GCP guideline
- measures to control adherence to GCP
The theoretical background will be applied to some practical exercises during the course.

Structured curriculum in the PhD, MD/PhD, DMD/PhD programme (0.5 ECTS)

Please note that thisis not a certified course for physicians planning to participate in clinicaltrials exploring drug or medical device properties, but an introductory course designedespecially for PhD students (and other interested parties). The course is opento participants from all disciplines.

Advisors: Dr. Franziska Schuster & Prof. Stefan Engeli
Date and Time: 15.10.2024; 09:00 to 16:00
Venue: in Greifswald, exact location to beannounced; transmission via Zoom will be available for external participants
Language: English
Number of participants: 20

Please register for this workshop at least 14 days before the course starts via our online course registration.

Further information
Graduiertenakademie der Universität Greifswald
Domstraße 11, Eingang 4, Raum 3.24, 17489 Greifswald
Telefon +49 3834 420 1618
graduiertenakademieuni-greifswaldde

 

Organisator

  • Graduiertenakademie der Universität Greifswald