SFKK18009U Regulatory Science
MSc Programme in Pharmacy or Pharmaceutical Sciences (Danish programmes cand.pharm and cand.scient.pharm) - elective
MSc Programme in Medicinal Chemistry - elective
MSc Programme in Pharmaceutical Sciences (English programme) - elective
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.
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.
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
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.
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
Background literature on applicable theory and research methods
Scientific literature
Relevant Regulatory Guidelines
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).
- Category
- Hours
- Course Preparation
- 56
- Lectures
- 50
- Study Groups
- 100
- Total
- 206
This course is not available for credit transfer students and other external students.
- Credit
- 7,5 ECTS
- Type of assessment
- Oral defenceIn order to obtain the course certificate the students should:
Participate to a satisfactory level
Submit written work
Take part in group presentation of written work.
Present individual written review
Be able to discuss and critique own and others work - Aid
- Written aids allowed
- Marking scale
- passed/not passed
- Censorship form
- No external censorship
Criteria for exam assesment
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
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.
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
Course information
- Language
- English
- Course code
- SFKK18009U
- Credit
- 7,5 ECTS
- Level
- Full Degree MasterFull Degree Master choice
- Duration
- 1 block
- Placement
- Block 4
- Schedule
- C
- Course capacity
- 60
- Study board
- Study Board of Pharmaceutical Sciences
Contracting department
- Department of Pharmacy
Contracting faculty
- Faculty of Health and Medical Sciences
Course Coordinators
- Christine Erikstrup Hallgreen (christine.hallgreen@sund.ku.dk)
Lecturers
Christine Erikstrup Hallgreen (zkj621)
Marie Louise De Bruin
External lectures