SMRMIF004U Regulatory Science – 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 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.
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
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.
• 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 (14 hours)
• Group assignment, case study (18 hours)
• Exam assignment (14 hours)
- Category
- Hours
- Exam Preparation
- 14
- Lectures
- 14
- Preparation
- 10
- Project work
- 18
- Total
- 56
Application deadline is 8 weeks before the first day of instruction
- Credit
- 2 ECTS
- Type of assessment
- Written assignmentThe student will be assessed based on a written assignment.
- Marking scale
- 7-point grading scale
- Censorship form
- No external censorship
- Exam period
The exam schedule is available on http://mra.ku.dk/calender/exams/
- Re-exam
Written response to critique of own report
The exam schedule is available on http://mra.ku.dk/calender/exams/
Criteria for exam assesment
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
Course information
- Language
- English
- Course code
- SMRMIF004U
- Credit
- 2 ECTS
- Level
- Part Time Master
- Duration
- 20 + 27 November 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 Professionel Master´s Degree Programmes at The Faculty og Health and Medical Science
Contracting department
- Department of Pharmacy
Course Coordinators
- Christine Erikstrup Hallgreen (19-6b707a717b7c71766d36706974746f7a6d6d76487b7d766c36737d366c73)