SFAK20009U Pharmacoepidemiology and Pharmacovigilance
MSc Programme in Medicinal Chemistry - elective
MSc Programme in Pharmacy (danish programme Cand.Pharm) - elective
MSc Programme in Pharmaceutical Science (danish programme Cand.Scient.Pharm) - restricted elective
MSc Programme in Pharmaceutical Sciences (english programme) - restricted elective
The principles of pharmacoepidemiology and pharmacovigilance are presented, including the related processes in the pharmaceutical industry and regulatory authorities. Lectures are supplemented with group discussions and exercises with calculations in a spreadsheet or statistical software. During the last weeks of the course, the students will in groups prepare a project report based on a case scenario where they develop and write up either an epidemiological study protocol, a risk management plan or a risk/benefit assessment. The written report is evaluated, presented orally and critically assessed by the other groups. Topics are:
- Introduction to pharmacovigilance
- Definitions, background and history
- Institutions and individuals involved in pharmacovigilance
- Sources of information on drug-related risks
- Pharmacoepidemiological methods
- Measures of occurrence and effect
- Cohort and case-control study designs
- Sources of error, bias and confounding
- Data sources, validity and limitations
- Analysis of epidemiological studies
- Drug utilisation studies and quality indicators of drug use
- Post-approval safety studies – protocols and practice
- Spontaneous reporting systems
- Individual case safety reports, clinical diagnosis coding and causality assessment
- Quantitative signal detection and signal evaluation
- Regulatory aspects of pharmacovigilance
- Pharmaceutical industry safety reporting and risk management plans
- Good pharmacovigilance practices
- Regulatory processes and decisions
- Benefit/risk assessment
The aim of the course is to give students knowledge about the principles of pharmacoepidemiology and pharmacovigilance. Additionally, to provide students with an understanding of the different types of evidence produced by experimental and observational studies of drug effects, and of the strengths and weaknesses of different study designs and methods. The students should be able to choose design and data sources that best fit the purpose of a study, and to critically evaluate published literature on drug safety, efficacy and effectiveness. They should be able integrate results from safety surveillance and post-approval studies with other preclinical and clinical safety information.
After completing the course the student is expected to be able to:
Knowledge
- understand pharmacoepidemiological and pharmacovigilance methods used to generate the evidence for benefit/risk assessments
- understand and explain central pharmacoepidemiological and pharmacovigilance concepts.
- explain principles of safety surveillance and risk management, including the obligations of the pharmaceutical industry and the basis for regulatory decisions.
- identify and summarise the limitations of pharmacoepidemiological studies and safety surveillance systems.
Skills
- describe, analyse and interpret the results of pharmacoepidemiological studies and safety surveillance.
- assess and discuss the limitations of data and methods in published literature and safety reports.
- summarise and prioritise safety information obtained with different methods in a structured way.
- communicate information on safety issues and drug-related risks.
Competences
- independently develop a protocol and plan for a post-authorisation safety study.
- perform a general benefit/risk assessment of a drug, integrating results from studies on efficacy and safety, data from safety surveillance systems and other information.
- outline a risk management plan for a marketed drug based on information on safety issues and patterns of use.
Selected textbook chapters, lecture notes, laws, documents, recommendations, circulars, guidelines and scientific papers.
Group and classroom discussions: 15 (45 min.)
Case project and report: 70
- Category
- Hours
- Lectures
- 40
- Preparation
- 81
- Theory exercises
- 10
- Exercises
- 5
- Project work
- 70
- Total
- 206
Open for credit transfer students and other external students. Apply here:
Credit transfer students:
Credit transfer student at SUND – University of Copenhagen (ku.dk)
Other external students:
http://healthsciences.ku.dk/education/student-mobility/guest-students/
- Credit
- 7,5 ECTS
- Type of assessment
- Course participationWritten assignment
- Type of assessment details
- Course certificate: During the last weeks of the course, the
students will in groups prepare a project report based on a case
scenario where they develop and write up either an epidemiological
study protocol, a risk management plan or a risk/benefit
assessment. The written report is evaluated, presented orally and
critically assessed by the other groups.
The assessment will be based on the project report and satisfactory participation in the course in general. - Marking scale
- passed/not passed
- Censorship form
- No external censorship
Criteria for exam assesment
To obtain a course certificate the student must be able to:
Knowledge
- understand pharmacoepidemiological and pharmacovigilance methods used to generate the evidence for benefit/risk assessments
- understand and explain central pharmacoepidemiological and pharmacovigilance concepts.
- explain principles of safety surveillance and risk management, including the obligations of the pharmaceutical industry and the basis for regulatory decisions.
- identify and summarise the limitations of pharmacoepidemiological studies and safety surveillance systems.
Skills
- describe, analyse and interpret the results of pharmacoepidemiological studies and safety surveillance.
- assess and discuss the limitations of data and methods in published literature and safety reports.
- summarise and prioritise safety information obtained with different methods in a structured way.
- communicate information on safety issues and drug-related risks.
Competences
- independently develop a protocol and plan for a post-authorisation safety study.
- perform a general benefit/risk assessment of a drug, integrating results from studies on efficacy and safety, data from safety surveillance systems and other information.
- outline a risk management plan for a marketed drug based on information on safety issues and patterns of use.
Course information
- Language
- English
- Course code
- SFAK20009U
- Credit
- 7,5 ECTS
- Level
- Full Degree MasterFull Degree Master choice
- Duration
- 1 block
- Placement
- Block 3
- Schedule
- C
- Course capacity
- 60 students
Study board
- Study Board of Pharmaceutical Sciences
Contracting department
- Department of Drug Design and Pharmacology
Contracting faculty
- Faculty of Health and Medical Sciences
Course Coordinators
- Morten Andersen
(15-7173767869723265726869767769724477797268326f7932686f)
Hovedansvarlig - Maurizio Sessa (14-506478756c7d6c723176687676644376787167316e7831676e)