Regulatory Science
Course content
The aim of the course is to give participants insight into and understanding of Regulatory Science as well as giving the participants a better understanding of the theories and methods available for analysing the effects of regulatory systems and interventions.
Pharmaceuticals are one of the most regulated products in society. The policies and regulations influencing the availability and use of pharmaceuticals are international, national and local. Regulators and drug developer must make decisions from the earliest preclinical stages through all phases of drug development.
The regulatory framework for medicines is constantly evolving. The system changes in order to adapt to scientific developments; address medical needs; bring medicines to patients earlier (and with better evidence); and also to keep prescribing information up to date. In Regulatory Science we seek to study and evaluate the regulatory system as such in terms of impact on ensuring patient safety, enhancing public health and stimulating the development of medicines.
MSc Programme in Medicinal Chemistry - elective
MSc Programme in Pharmacy (Danish programme cand.pharm) - elective
MSc Programme in Pharmaceutical Sciences (Danish programme cand.scient.pharm) - restricted elective
MSc Programme in Pharmaceutical Sciences (English programme) - restricted elective
On completion of the course participants should be able to:
Knowledge
-
Understand the current regulatory system of medicines
-
Understand the political and legal framework of drug regulation
-
Describe the traditional process of drug discovery and development, and relate this to the current regulatory framework
-
Describe various research approaches applied in regulatory science
-
Describe use of strategies and existing data sources for to be used in Regulatory Science research
Skills
-
Identify and conceptualise relevant regulatory science research question and hypothesis, through analysing the scientific literature in context of regulatory systems
-
Plan the research process for and carry out a regulatory science study
-
Identify and apply approaches and methods to address Regulatory Science research questions
-
Identify appropriate data sources, and methods for data extraction and validation, to study a regulatory science research question.
-
Use and analyse quantitative data to study regulatory science research questions
Competences
-
Discuss and critique Regulatory Science research and its implications
-
Effectively communicate the value of Regulatory Science, including priorities and gaps to stakeholders, including colleagues, policy makers, the media, and the public
Lectures and teaching in classes (50 hours in total).
Group case work including preparation of written reports and oral
presentations as well as smaller individual assignments (100 hours)
Preparation for classes, self-study (56 hours).
Background literature on applicable theory and research methods
Lecture notes e.g. Slides and presentations
Scientific literature
Relevant Regulatory Guidelines and laws
A bachelor’s degree in health, natural or technical sciences.
None.
This course is not available for credit transfer students and other external students.
- ECTS
- 7,5 ECTS
- Type of assessment
-
Oral defenceCourse participation
- Type of assessment details
- In order to obtain the course certificate the students should:
Participate to a satisfactory level
Submit written work
Take part in group and/or individuel presentation of written work.
Discuss and critique own and others work - Aid
- Written aids allowed
- Marking scale
- passed/not passed
- Censorship form
- No external censorship
Criteria for exam assessment
To obtain a course certificate the student should be able to:
Knowledge
-
Understand the current regulatory system of medicines
-
Understand the political and legal framework of drug regulation
-
Describe the traditional process of drug discovery and development, and relate this to the current regulatory framework
-
Describe various research approaches applied in regulatory science
-
Describe use of strategies and existing data sources for to be used in Regulatory Science research
Skills
-
Identify and conceptualise relevant regulatory science research question and hypothesis, through analysing the scientific literature in context of regulatory systems
-
Plan the research process for and carry out a regulatory science study
-
Identify and apply approaches and methods to address Regulatory Science research questions
-
Identify appropriate data sources, and methods for data extraction and validation, to study a regulatory science research question.
-
Use and analyse quantitative data to study regulatory science research questions
Competences
-
Discuss and critique Regulatory Science research and its implications
-
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
- 50
- Preparation
- 56
- Study Groups
- 100
- English
- 206
Kursusinformation
- Language
- English
- Course number
- SFAK20044U
- ECTS
- 7,5 ECTS
- Programme level
- Full Degree Master
Full Degree Master choice
- Duration
-
1 block
- Placement
- Block 4
- Schedulegroup
-
C
- Capacity
- 60
- Studyboard
- Study Board of Pharmaceutical Sciences
Contracting department
- Department of Pharmacy
Contracting faculty
- Faculty of Health and Medical Sciences
Course Coordinator
- Christine Erikstrup Hallgreen (19-656a746b75766b7067306a636e6e69746767704275777066306d7730666d)
Teacher
Christine Erikstrup Hallgreen (zkj621)
Marie Louise De Bruin
External lectures
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Courseinformation of students