Regulatory Affairs in the EU

Aim

The course provides a comprehensive overview of the pharmaceutical law frames in the EU and conveys an understanding of the background and the development of pharmaceutical legislation in the EU with regard to applications for pharmaceutical marketing authorisations, clinical trials and other pharmaceutical relevant applications.

Location & Organization

Organizer

MPRA – Master of Pharmaceutical Regulatory Affairs

Location / venue

University of Copenhagen (Faculty of Health and Medical Sciences)

Timing & Workload

Duration Segmental
ECTS points 6
Frequency Annual /biennial
 

Examination yes

Criteria

Is the course taught in English? yes
Is documentation available? (book, syllabus)? yes
Is the course open for external researchers? yes

Remarks

The applicant must have a relevant educational background at Bachelor level and at least 2 years experience within Drug Regulatory Affairs or equivalent qualifications

More Information

http://www.farma.ku.dk/index.php/Regulatory-Affairs-in-the-EU/3845/0/