Regulatory Science – Perspectives on Clinical Development

Course content

The aim of the course is to enable the students to critically reflect and discuss previously obtained knowledge about guidelines and regulations for clinical development of medicine, through the introduction of regulatory science research. 

The course will centre around 3-4 topical subjects, this could be regulatory science research on topics such as:  

  • Patient involvement in drug development
  • Benefit-risk assessment
  • Accelerated approval pathways

 

The course can serve as an extension of the course ‘Clinical Development – Efficacy of medicines’, but can also be taken independently.

Education

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

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

Learning outcome

After this course, the student will be able to

Knowledge

  • Explain the perspectives of current regulatory frameworks in clinical drug development
  • Explain  requirements including possible challenges, for obtaining marketing authorisation, and possible implications of these 

 

Skills

  • Evaluate and discuss research results within Regulatory Science
  • Critically reflect on the appropriateness of different regulatory strategies
  • Discuss the advantages of latest regulatory innovations in in clinical drug development

 

Competencies

  • Impact discussions on strategic regulatory decisions

 

• Preparation (10 hours)
• Lectures and class discussions (14 hours)
• Group assignment, case study (18 hours)
• Exam assignment (14 hours)

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.

Applicants must meet the following criteria:
• A relevant bachelor degree or equivalent
• A minimum of 2 years of relevant job experience
• Proficiency in English

It is recommended that the participant have passed the course ‘Clinical Development – Efficacy of medicines’ or equivalent course.

ECTS
2 ECTS
Type of assessment
Written assignment
The student will be assessed based on a written assignment.
Marking scale
7-point grading scale
Censorship form
No external censorship
Criteria for exam assessment

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

Knowledge

  • Explain the perspectives of current regulatory frameworks in clinical drug development
  • Explain  requirements including possible challenges, for obtaining marketing authorisation, and possible implications of these 

 

Skills

  • Evaluate and discuss research results within Regulatory Science
  • Critically reflect on the appropriateness of different regulatory strategies
  • Discuss the advantages of latest regulatory innovations in in clinical drug development

 

Part time Master and Diploma courses

  • Category
  • Hours
  • Preparation
  • 10
  • Lectures
  • 14
  • Project work
  • 18
  • Exam Preparation
  • 14
  • English
  • 56