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.
Strukturiertes Curriculum im PhD, MD/PhD, DMD/PhD-Programm
Pflichtcurriculum mit 0,5 ECTS: Gute Klinische Praxis
Please note that this is not a certified course for physicians planning to participate in clinical trials exploring drug or medical device properties, but an introductory course designed especially for PhD students (and other interested parties). The course is open to participants from all disciplines.
Advisors: Dr. Franziska Schuster & Prof. Stefan Engeli, Coordinating Center for Clinical Studies (KKS), University Medicine Greifswald
Date and Time: May 22, 2025 09:00 to 15:00 (30 min break)
Venue: Praktikumsgebäude UMG, Room No. 6 (Q 0.09); transmission via Zoom will be available for external participants
Language: English
Number of participants: 18
Please register for this workshop via our online course registration.
Contact
Graduiertenakademie der Universität Greifswald
Domstraße 11, Eingang 4, Raum 3.24, 17489 Greifswald
Telefon +49 3834 420 1618
graduiertenakademieuni-greifswaldde