SFAK25008U Regulatory Science

Volume 2025/2026
Education

MSc Programme in Pharmaceutical Sciences (English programme) track III- compulsory

MSc Programme in Pharmaceutical Sciences (English programme) track I & II - restricted elective

MSc Programme in Medicinal Chemistry - elective

MSc Programme in Pharmacy (Danish programme cand.pharm) - elective

MSc Programme in Pharmaceutical Sciences (Danish programme cand.scient.pharm) - restricted elective

 

Content

The primary goal of this course is to provide students with a comprehensive understanding of the European Union's legal framework for medicinal products. This includes insight into the EU legal system and the legislative structure governing these products. Moreover, students will also gain an understanding on how EU pharmaceutical regulations are put into practice. This encompasses various procedural aspects, such as the application process for marketing authorisations, the conduct of clinical trials, orphan designation, paediatric development, and risk management.

Throughout the course, students will be introduced to diverse facets of the EU regulatory framework. They will gain insights into how the EU regulatory system functions and understand the various regulatory pathways and procedures involved in the life cycle of medicinal products. This understanding will be achieved through the analysis and discussion of specific sections of EU pharmaceutical directives and regulations, selected guidelines, real-world case examples, and in-depth studies in regulatory science. Regulatory science studies and case examples of regulatory decisions and procedures will play a key role throughout the course to substantiate the students understanding and reflections on the functioning of the regulatory system and its implications for industry, patients, and society.

Learning Outcome

On completion of the course participants should be able to:

Knowledge

  • Understand the legal framework and regulatory system for medicinal products in the EU.
  • Understand and describe different regulatory pathways for marketing authorisation in the EU.
  • Understand and descript key regulatory procedures relevant for all medicinal products as well as in specific cases (e.g orphan designation) throughout their product life-cycle.
  • Read and understand regulatory science studies.

Skills

  • Identify, analyse and consider regulatory opportunities and consequences related to different types of medicinal products and submissions e.g. conditional approval, orphan medical products, etc.
  • Critically appraise regulatory science studies and reflect on possible implications of the results to our understanding of the functioning of the regulatory system.
  • Identify and conceptualise relevant regulatory science research questions and hypotheses, through analysing the scientific literature in context of regulatory systems.

Competences

  • Discuss and critique the implementation of pharmaceutical legislation and its implications for industry, patients, and society.
  • Effectively communicate the value of Regulatory Science, including priorities and gaps to stakeholders, including colleagues, policy makers, the media, and the public
  • Relevant Regulatory Guidelines and laws, and other regulatory documents
  • Scientific literature
  • Lecture notes 

 

 

A bachelor’s degree in health, natural or technical sciences.
Lectures, workshops, group and individual assignments
  • Category
  • Hours
  • Lectures
  • 33
  • Class Instruction
  • 18
  • Preparation
  • 100
  • Project work
  • 50
  • Exam
  • 6
  • Total
  • 207
Oral
Collective
Continuous feedback during the course of the semester
Peer feedback (Students give each other feedback)
Credit
7,5 ECTS
Type of assessment
Home assignment, 6 timer
Type of assessment details
The home assignment is an essay-type assignment with 4-6 questions relating to the regulatory framework for medicinal products. The exam assignment will be available 6 hours prior to exam deadline
Aid
All aids allowed
Marking scale
7-point grading scale
Censorship form
No external censorship
Criteria for exam assesment

To obtain a course certificate the student should be able to:

Knowledge

  • Understand the legal framework and regulatory system for medicinal products in the EU.
  • Understand and describe different regulatory pathways for marketing authorisation in the EU.
  • Understand and descript key regulatory procedures relevant for all medicinal products as well as in specific cases (e.g orphan designation) throughout their product life-cycle.
  • Read and understand regulatory science studies.

Skills

  • Identify, analyse and consider regulatory opportunities and consequences related to different types of medicinal products and submissions e.g. conditional approval, orphan medical products, etc.
  • Critically appraise regulatory science studies and reflect on possible implications of the results to our understanding of the functioning of the regulatory system.
  • Identify and conceptualise relevant regulatory science research questions and hypotheses, through analysing the scientific literature in context of regulatory systems.

Competences

  • Discuss and critique the implementation of pharmaceutical legislation and its implications for industry, patients and society.
  • Effectively communicate the value of Regulatory Science, including priorities and gaps to stakeholders, including colleagues, policy makers, the media, and the public