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Drug Development and Regulation (7.5 ECTS)

Thursday 20 March 2014

This course is organized by the UU master Drug Innovation, and most of the students in the course were in that program.

The course is mainly focused on the group project: making a drug development plan based on a given scientific article. There were quite some lectures in the first two weeks, but they all focused on things you had to learn to do the assignment. The drug development plan was made in groups of five students and accounted for 40% of the grade. Other assements were ‘decision point’ presentations (your group received fictious data related to the article given and had to decide to continue to 1) clinical trials or 2) phase III); a final presentation of the development plan; and an individual assignment (writing a peer review of another group’s development plan)

While the decision point component of the course needs some work to get to the quality level of the rest of the course, the assessment methods were a very good way to learn about the subject and to test what you’ve learned. It’s a course that is sufficiently challenging and it’s quite a bit of work to do it right, but it is very nice if you’re interested in drug development and all of the international regulations that developers have to adhere to.

Anniek van der Helm
February-March 2014 (5 weeks)