SMRMIF006E  Exam in Quality – Active Substance and Medicinal Product

Volume 2017/2018
Education

This exam is offered in collaboration between University of Copenhagen and Medicademy as part of the Master of Medicines Regulatory Affairs. It is possible to follow the exam as a single course student.

Credit
1 ECTS
Type of assessment
Written assignment, 3 hours
3 hours written assignment with descriptive questions and multiple choice held on Digital Exam - The online platform for examination at the University of Copenhagen.
Exam registration requirements

Students must have passed the course SMRMIF006U Quality – Active Substance and Medicinal Product in order to participate in the examination

Aid
All aids allowed
Marking scale
passed/not passed
Censorship form
No external censorship
Exam period

Exam schedule is published on http://mra.ku.dk/calender/exams/

Re-exam

Exam schedule is published on http://mra.ku.dk/calender/exams/

Criteria for exam assesment

To achieve the grade passed, the student shall (in an adequate level) be able to:

Knowledge

  • Explain and discuss regulatory quality documentation in regards to medicinal product development

  • Explain and identify the basic principles of regulatory quality documentation and how this work is regulated through guidelines and standards

  • Explain and discuss how quality build into daily activities may improve performance and may result in faster submissions and approvals

 

Skills

  • Apply and analyse development processes, reports, specifications, methods and data to ensure coherency and transparency of the quality dossier and compliance with required guidelines and quality standards

  • Analyse and discuss the CMC documentation in relation to the clinical phases

 

Competences

  • Prepare quality plans and describe decision steps with regard to pharmaceutical development and documentation

  • Category
  • Hours
  • Exam
  • 3
  • Exam Preparation
  • 24
  • Total
  • 27