FARM5220 – A real-world approach to pharmacoepidemiology and pharmacovigilance
Schedule, syllabus and examination date
Changes in the course due to coronavirus
Autumn 2020 and Spring 2021 the exams of most courses at the MN Faculty will be conducted as digital home exams or oral exams, using the normal grading scale. The semester page for your course will be updated with any changes in the form of examination.
Please note that there may be changes in the form of examination for some courses taught Spring 2021. We aim to bring both the course description and the semester page of all courses up to date with correct information by 1 February 2021.
This course bridges the themes of advanced pharmacoepidemiology and pharmacovigilance, and equips students with knowledge, practical analytical skills and competences to develop, apply and critically appraise the methods used to generate the evidence for benefit-risk assessments of medications. Students will get hands-on experience with real-world data and techniques to monitor effectiveness and safety of medications after marketing approval. Signal detection approaches using adverse drug reaction databases and knowledge about regulatory actions taken in response to safety signals on marketed medications is part of this course.
After completing the course you:
- have an in-depth knowledge of the pharmacovigilance system, including the spontaneous reporting system, signal management and risk management plans
- can use knowledge of fundamental and more advanced pharmacoepidemiological methods to appraise and assess real-world evidence on effectiveness and safety of medications
- can outline a risk management plan for a marketed medicinal product
- have acquired in-depth knowledge of the process changing drug labelling (Summary of Product Characteristics and Package Information Leaflet)
- can communicate drug-related risks and effectiveness data to healthcare personnel and lay persons
- can evaluate the strengths and weaknesses of commonly used risk minimization measures for marketed medicinal products
Admission to the course
The course is primarily open to students who have been admitted to the Department of Pharmacy at the University of Oslo. If there is space available then others may also apply to take the course as long as their academic background is adequate.
Formal prerequisite knowledge
the compulsory parts of FARM4100 – Personalised Drug Therapy
the compulsory parts of FARM4110 – Comprehensive Biopharmacy and Formulation Technology
the compulsory parts of FARM4120 – Drug Development
the compulsory HMS-courses HMS0501 – Safety and Physical Environment, HMS0502 – Positive Learning Environment, HMS0503 – Laboratory Safety, HMS0506 – Patient Clinic Safety and HMS0507 – Fire Safety required for students at the 5-year Master`s Program in Pharmacy.
For students admitted to the 5-year Master`s Program in Pharmacy until and including 2016 and who have been transferred from the old study plan, separate formal prerequisite knowledge apply. These are in professional compliance with the formal prerequisite knowledge that apply to the course, but may be replaced by courses from the old study plan, as well as transitional courses. Students on transitional arrangements may contact the study administration for å complete overview of the formal prerequisite knowledge required.
The course is only available to students who have passed their pharmacy apprenticeship and have passed all previous pharmacy courses or have the equivalent academic background.
Lectures and student-active teaching, including computer lab, web-based forum and journal club .
- 10 hours lectures
- 14 hours data lab (mandatory)
- 8 hours web-based forum for discussion and journal club (mandatory)
Mandatory participation in the course work as well as compulsory submission of data-lab report must be completed and approved before sitting the exam.
Access to teaching
A student who has completed compulsory instruction and coursework and has had these approved, is not entitled to repeat that instruction and coursework. A student who has been admitted to a course, but who has not completed compulsory instruction and coursework or had these approved, is entitled to repeat that instruction and coursework, depending on available capacity.
Compulsory participation and approved assignments are valid for 3 years.
The course may be cancelled if the number of enrolled students are low.
Final home exam over 2 weeks, which counts 100 % towards the finale grade.
This course has mandatory exercises that must be approved before you can sit the finale exam.
When writing your exercises make sure to familiarize yourself with the rules for use of sources and citations.
Breach of these rules may lead to suspicion of attempted cheating.
Plagiarism checks will be performed.
Examination support material
Students may use any aids they require. You will have access to a calculator in Inspera during the exam.
Language of examination
The examination text is given in English.You may submit your response in Norwegian, Swedish, Danish or English.
Grades are awarded on a scale from A to F, where A is the best grade and F is a fail. Read more about the grading system.
Resit an examination
This course offers both postponed and resit of examination. Read more: