Clinical drug research

Course Code :2032FBDBMW
Study domain:Biomedical Sciences
Academic year:2019-2020
Semester:2nd semester
Contact hours:45
Credits:6
Study load (hours):168
Contract restrictions: Exam contract not possible
Language of instruction:English
Exam period:exam in the 2nd semester
Lecturer(s)Pierre Van Damme
Elke Leuridan
Koen Van Herck
Kirsten Maertens

3. Course contents *

Building upon the foreknowledge of the course on Preclinical (Non-clinical) Drug Research, you get an overview of the whole process of Clinical Drug Research. Using the "standard" drug development as an example, some particular other settings (paediatric clinical trials, medical device studies, vaccine trials) are also discussed. The current rules and regulations are explained and put into a historical perspective.

You get to know the different actors involved in clinical drug research, their respective roles and the way they interact between one another. Some standard documents and procedures are explained. This thanks to the involvement of guest speakers from the filed of clinical trials (CRO-, pharma-, biotech-industry, chairman of the Ethics Committee, ...).
Near the end of the course we look into the role of the regulating bodies, the registration of new drugs, and into some future trends in clinical research. The course takes a Belgian perspective, while respecting the Europian and the international context of clinical research.

You will be allowed to get acquainted with a number of standard documents, to master clinical trial-related information and to report orally and in writing to different target audiences (= permanent evaluation during the semester)