The course objectives are to provide a general introduction to practical, methodological and regulatory aspects of drug trials in humans. The course is not a GCP course.

The clinical development phases will be presented, along with non-clinical studies that are a direct prerequisite for clinical trials. Other topics, which will be covered, include:

• Clinical trial protocol.
• Clinical trial methodology.
• Randomised clinical trial.
• Pharmacovigilance.
• Health economics.
• Statitics in clinical trials.
• Quality assurance.
• Regulatory guidelines.
• Regulatory drug approval process.
• Evidence-based medicine and ethics in clinical drug trials.

The course will last 5 days and will comprise mainly lectures, but also discussions and workshops.

A copy of the study material will be provided at the start of the course. There will be no formal examination, but to complete the course satisfactorily the participants need to take an active part in the course.

21 to 25 May 2012.

4 ECTS credit points (European Credit Transfer System).

105 working hours (40 for preparation, 30 for course, and 35 for evaluation).

Contact person at the Faculty of Pharmaceutical Sciences, University of Copenhagen is Professor Lona L. Christrup, Department of Pharmacology and Pharmacotherapy.

Presenters at the course will be experts from the various disciplines, e.g. from regulatory authorities, academia, drug industry or other business areas related to drug development.

Total course fee: DKK 8,200 (including lunch),

of which operating costs: DKK 1,500.

1 April 2012.

20 participants.

The target group will be PhD students within pharmaceutical sciences. Other graduates holding degrees in health/life sciences at university level, but who have no in-depth knowledge of clinical drug trials, are also welcome to attend.

The course will only be held in Danish.

A special note to MIND students: The course is not accepted as an elective course in the MIND program.