FARM5220 – A real-world approach to pharmacoepidemiology and pharmacovigilance
Course content
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.
Learning outcome
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.
- have knowledge of how the risk minimization plan for a marketed medicinal product is prepared and you will be able to propose relevant risk minimization measures for a risk management plan.
- can evaluate the strengths and weaknesses of commonly used risk minimization measures for marketed medicinal products.
- 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.
Admission to the course
The course is mainly open to students who have been admitted to the 5-year Master`s Programme in Pharmacy at the Department?of Pharmacy, University of Oslo. In the event that space is available, other master`s level students may apply. Knowledge in relevant subject area corresponding to the content of Semester 1 through 7 at the department’s Master`s Programme in Pharmacy is required. For more information, please contact the Study Administration at the Department of Pharmacy, studieinfo@farmasi.uio.no.
Formal prerequisite knowledge
Passed the exam in:
- FARM1100 – Pharmaceutical Chemistry
- FARM1110 – Pharmacology, Physiology and Cell Biology 1
- FARM1120 – Social Pharmacy
- FARM1130 – Pharmaceutically Based Organic Chemistry
- FARM1140 – Pharmacology, Physiology and Cell Biology 2
- FARM1150 – Pharmaceutical Based Biochemistry
- FARM2100 – Medicinal Chemistry
- FARM2110 – Pharmacotherapy 1
- FARM2120 – Pharmaceutics and Biopharmaceutics
- FARM2130 – Pharmaceutical Analytical Chemistry
- FARM2140 – Pharmaceutical Microbiology
- FARM2150 – Formulation of Drugs and Quality Assurance in Drug Production
- FARM3100 – Pharmacognosy
- FARM3110 – Pharmacotherapy 2
- FARM3120 – Medicine Use and Public Health
- FARM3130 – Advanced Pharmacy Practice Experience (APPE)
- 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 Programme in Pharmacy.
Approved the compulsory parts of:?
- FARM4100 – Personalised Drug Therapy
- FARM4110 – Comprehensive Biopharmacy and Formulation Technology
- FARM4120 – Drug Development
Formal prerequisite knowledge for students admitted to Studiel?p for farmas?yter med mastergrad fra land utenfor EU/E?S:
- FARM4910K – Farmakoterapi og samfunnsfarmasi med fokus p? norske terapitradisjoner og norske forhold
- FARM4920K – Fra virkestoff til ferdig formulering med fokus p? avanserte legemiddelformer
- FARM4930K – Kvalitetssikring ved produksjon og klinisk utpr?vning av legemidler
- approved 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 Programme in Pharmacy.
For students admitted to the 5-year Master`s Programme 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 a complete overview of the formal prerequisite knowledge required.
Teaching
Lectures, internship at pharmaceutical company, student-active teaching, including computer lab and discussion groups.
- 9 hours lectures
- 8 hours data lab and 2 hours presentation of results (compulsory)
- 9 hours forum for discussion/colloquium?(compulsory)
- 2 days internship at?a pharmaceutical company
- 1 day excursion/teaching at a pharmaceutical company about use of real-world-evidence (RWE)-data in clinical development of medicines?
Compulsory participation in the course work as well as compulsory submission of data-lab report must be completed and approved before sitting the exam.?
Read more about what applies in the event of absence from compulsory activities.
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.
Examination
- Final written exam which counts 100 % towards the final?grade.?
For admission to the exam, the following must be approved:
- Datalab and presentation of results from datalab
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 are not allowed to bring and use any aids during the exam. 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.
Grading scale
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:
More about examinations at UiO
- Use of sources and citations
- Special exam arrangements due to individual needs
- Withdrawal from an exam
- Illness at exams / postponed exams
- Explanation of grades and appeals
- Resitting an exam
- Cheating/attempted cheating
You will find further guides and resources at the web page on examinations at UiO.