Examination – University of Copenhagen

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Examination in:

Quality by Design (QbD) in Pharmaceutical Development

Type of examination

An essay based on a selected QbD case and the common course syllabus. The essay must be 8–15 pages long. The common course syllabus is a collection of legislation, presentations (hand-outs) and cases, approx. 300 pages.

Active participation in the course is required.

Deadline for submission in Digital Eksamen : 2 October at 2 p.m.

Assessment

Pass/Fail

Pass criteria

To pass the exam, the participant must have:

  • Written a comprehensive and structured report on a selected case in their own words based on relevant literature.
  • Demonstrated the ability to find, understand and report relevant literature for the selected case.
  • Demonstrated knowledge of the principles and terms used in the field of QbD in pharmaceutical development.
  • Demonstrated an understanding of the central concepts and disciplines relevant for the selected case.

Examiners

Professor Jukka Rantanen (PhD), Department of Pharmaceutics and Analytical Chemistry, University of Copenhagen, and Honorary Associate Professor Poul Bertelsen (PhD), University of Copenhagen.

Course credits

3 ECTS credits = a student workload of approx. 82 hours

Level

Master’s level (second-cycle higher education)

Certificate

After passing the exam, participant will receive a certificate from the University of Copenhagen stating the course title, contents, credits and level.