Perspectives on Clinical Development

Course content

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

The course may include regulatory science reseach on topich such as:

  • discrepancies between risk-benefit assessed by legislators, companies and patients
  • alternative regulatory pathways in clinical development and methodological challenges connected to these
  • patient involvement in assessment procedures.

 

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 background and  perspectives of current legislation 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
  • Discuss and compare the advantages of different methodological approaches in clinical drug development 

 

Competencies

  • Discuss implication of changes in the regulatory framework on Benefit-risk assessment for a given material
  • Critically reflect on the appropriateness of the chosen methodologies of assessing effects and safety of medicinal products
  • Critically reflect and discuss current guidelines and regulations for clinical development of medicine

• Preparation (10 hours)
• Lectures and class discussions (12 hours)
• Group assignment, case study (20 hours)
• Exam assignment (14 hours)

The syllabus comprises relevant EMA and ICH guidelines, EC legislation, and 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:
• One written assignment
• Written critique on one fellow students written assignment
Both have to be fulfilled to pass the course.
Marking scale
7-point grading scale
Censorship form
No external censorship
Criteria for exam assessment

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

Knowledge

  • Explain the background and  perspectives of current legislation 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
  • Discuss and compare the advantages of different methodological approaches in clinical drug development

 

Competencies

  • Discuss implication of changes in the regulatory framework on Benefit-risk assessment for a given material

Part time Master and Diploma courses

  • Category
  • Hours
  • Preparation
  • 10
  • Lectures
  • 12
  • Project work
  • 20
  • Exam Preparation
  • 14
  • English
  • 56