SMRM18006U Drug Regulatory Science

Volume 2025/2026
Education

This course is a compulsory course at Copenhagen University's Master of Medicines Regulatory Affairs (MRA).

 

See course webpage for course dates.

 

This course is compulsory at the 2018-curriculum

The course is open to single course students and students from other master's programmes.

Content

The course will enable the students to impact discussions on strategic regulatory decisions, and to critically reflect and discuss previously obtained knowledge about guidelines and regulations for clinical development of medicine. 

Regulatory science research will set the foundations for class discussion centred around research methodology and methods, identification of data sources, and interpretation of research results.

The course will centre around 3-4 regulatory science research topics such as, patient involvement in drug development, benefit-risk assessment or accelerated approval pathways. During the course, the students will also be introduced to both qualitative and as quantitative research methods in regulatory science. 

 

 

Learning Outcome

After this course, the student will be able to

Knowledge

  • Describe various research approaches applied in Drug Regulatory Science

  • Describe use of strategies and data sources for to be used in Drug Regulatory Science research

Skills

  • Identify and conceptualise relevant Drug Regulatory Science research question and hypothesis, through analysing the scientific literature in context of regulatory systems

  • Identify approaches and methods to address Drug Regulatory Science research questions

  • Discuss the advantages and challenges with recent regulatory innovations for drug development

 

Competencies

  • Reflect on implications of results within Drug Regulatory Science, with the perspective of the society, academia and industry
  • Identify and conceptualise relevant Drug Regulatory Science research question and hypothesis, through analysing the scientific literature in context of regulatory systems
  • Impact discussions on strategic regulatory decisions

 

The syllabus comprises a selection of book chapters, scientific papers and review papers.

A complete list of reading material will be distributed electronically before the course.

Basic knowledge of drug regulation systems, 1. acquired in MRA courses such as ‘The US regulatory environment’ and ‘The EU regulatory environment’ or otherwise OR 2. acquired in the MIND course- Drug Regulatory Affairs in Drug Development, is an advantage in the course.
Lectures, class discussions and group work
  • Category
  • Hours
  • Lectures
  • 21
  • Preparation
  • 30
  • Project work
  • 18
  • Exam Preparation
  • 14
  • Total
  • 83
Oral
Peer feedback (Students give each other feedback)
Credit
3 ECTS
Type of assessment
Written assignment
Type of assessment details
The student will be assessed based on a written assignment.
Aid
All aids allowed

All aids allowed for preparation including access to internet and the use of Generative AI.

It is the responsibility of the student to ensure the accuracy, integrity, and originality of the text, including ensuring that the text is not factually incorrect, plagiarized, or contains copyrighted material. AI/LLM’s may not be used as an actual author or a scientific source cf. Vancouver Guidelines.

Marking scale
7-point grading scale
Censorship form
No external censorship
Exam period

See exam schedule.

Re-exam

The exam form for the reexam is the same as the ordinary exam. See dates in the exam schedule.

Written response to critique of own report

Criteria for exam assesment

To achieve the maximum grade of 12, the student should be able to:

Knowledge

  • Describe the research approaches applied in a Drug Regulatory Science
  • Describe use of strategies and data sources in Drug Regulatory Science research

 

Skills

  • Discuss choice of research approaches and data sources in Drug Regulatory Science
  • Identify relevant results in Drug Regulatory Science in context of the regulatory systems

 

Competencies

  • Reflect on implications of results within Drug Regulatory Science, with the perspective of the society, academia and industry
  • Identify and conceptualise relevant Drug Regulatory Science research question and hypothesis, through analysing the scientific literature in context of regulatory systems