SMRMIF004U Perspectives on Clinical Development
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.
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.
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
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.
• 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.
• Lectures and class discussions (12 hours)
• Group assignment, case study (20 hours)
• Exam assignment (14 hours)
- Category
- Hours
- Exam Preparation
- 14
- Lectures
- 12
- Preparation
- 10
- Project work
- 20
- Total
- 56
- Credit
- 2 ECTS
- Type of assessment
- Written assignmentThe 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
- Re-exam
Written response to critique of own report as well as written critique of one fellow student's report
Criteria for exam assesment
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
Course information
- Language
- English
- Course code
- SMRMIF004U
- Credit
- 2 ECTS
- Level
- Part Time Master
- Duration
- 4 May + 11 May 2017
- Placement
- Spring
- Schedule
- 2 days (1 + 1)
- Continuing and further education
- Price
Prices vary according to type of enrolment and nationality. For details please visit:
Fee includes course materials and lunch/coffee. Textbook must be purchased by the participants.
- Study board
- Study Board for the Professional Master’s Degree Programmes at The Faculty of Health and Medical Sciences
Contracting department
- Department of Pharmacy
Course responsibles
- Christine Erikstrup Hallgreen (19-717680778182777c733c766f7a7a758073737c4e81837c723c79833c7279)