Regulatory Science
Course 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.
BSc Programme in Pharmacy - elective
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 descripbe key regulatory procedures relevant for all medicinal products as well as for 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 of 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
Lectures, workshops, group report
- Relevant Regulatory Guidelines and laws, and other regulatory documents
- Scientific literature
- Lecture notes
Teaching is based on the assumption that the students have acquired knowledge, skills and competences corresponding to those obtained by completion of the first five semesters of the BSc Program in Pharmacy.
This course is not available for credit transfer students and other external students.
- ECTS
- 7,5 ECTS
- Type of assessment
-
Oral exam on basis of previous submission, 15 min
- Type of assessment details
- 15-minute individual oral examination based on the submitted group report and the course teaching material. The examination will include questions related to the regulatory case(s) addressed in the report, as well as broader questions covering the learning outcomes of the course.
- Examination prerequisites
-
To be eligible for the oral examination, the student must have submitted a group report addressing one or more regulatory science cases or problems within the scope of the course teaching material. Groups will normally consist of four students but may be adjusted according to course enrolment. The report is not graded.
If a student has not submitted a group report prior to the ordinary examination, an individual report must be submitted in order to be eligible for the re-examination.
- Aid
- Only certain aids allowed (see description below)
For the oral exam the student can bring the group report submitted by the student.
- Marking scale
- 7-point grading scale
- Censorship form
- No external censorship
- Re-exam
-
15-minute individual oral examination based on the submitted report and the course teaching material.
If the student submitted a group report for the ordinary examination, no new report is required, and the previously submitted report will form the basis for the re-examination. If the student did not submit a group report for the ordinary examination, an individual report must be submitted before the re-examination and will form the basis for the oral examination.
The examination will include questions related to the regulatory case(s) addressed in the report, as well as broader questions covering the learning outcomes of the course.
Criteria for exam assessment
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 descripbe key regulatory procedures relevant for all medicinal products as well as for 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 of 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
- Effectively communicate the value of Regulatory Science, including priorities and gaps to stakeholders, including colleagues, policy makers, the media, and the public
- Category
- Hours
- Lectures
- 33
- Class Instruction
- 18
- Preparation
- 104
- Project work
- 50
- Exam
- 1
- English
- 206
Kursusinformation
- Language
- English
- Course number
- SFAB25002U
- ECTS
- 7,5 ECTS
- Programme level
- Bachelor
Bachelor choice
- Duration
-
1 block
- Placement
- Block 4
- Schedulegroup
-
A
- Capacity
- 25
- Studyboard
- Study Board of Pharmaceutical Sciences
Contracting department
- Department of Pharmacy
Contracting faculty
- Faculty of Health and Medical Sciences
Course Coordinator
- Christine Erikstrup Hallgreen (19-686d776e78796e736a336d6671716c776a6a7345787a736933707a336970)
Teacher
Staff primarily in Copenhagen Center for Regulatory Science
External lectures
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Kursusinformation for indskrevne studerende