Clinical Development and Documentation

Aim

To provide a comprehensive understanding of the requirements for the clinical documentation required for a Marketing Authorisation.

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/Clinical-development-and-docum/3875/0/