SMRMIF001E  Exam in Regulatory Affairs in the USA

Volume 2017/2018

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.

Learning Outcome

differences between FDA and EMA requirements

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

Students must have passed the course SMRMIF001U Regulatory Affairs in the USA in order to participate in the examination

All aids allowed
Marking scale
passed/not passed
Censorship form
No external censorship
Criteria for exam assesment

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


  • Understand the structure of the FDA and the legal basis for the FDA’s role in US drug regulation

  • Describe requirements for key FDA submissions

  • Correctly match regulatory compliance requirements for CMC, nonclinical, and clinical study content


  • Correctly identify timelines and requirements for FDA interactions, submissions, and reviews


  • Correctly identify FDA-specific regulatory requirements and key differences vs EMA
  • Category
  • Hours
  • Exam
  • 3
  • Exam Preparation
  • 24
  • Total
  • 27