FARM5220 – A real-world approach to pharmacoepidemiology and pharmacovigilance

After completing the course, you can:

• Explain the European pharmacovigilance systems, including the spontaneous reporting system, handling of adverse reaction signals and risk management plans.
• Use your knowledge of basic and more advanced pharmacoepidemiological methods to assess and analyze real-world data on efficacy and safety of medicinal products.
• Explain how a risk minimization plan for a marketed medicinal product is prepared and propose and discuss relevant risk minimization measures.
• Evaluate the strengths and weaknesses of commonly used risk minimization measures for marketed medicinal products.
• Explain the process for updating product information (Summary of Product Characteristics and Package Leaflet) and assess how new data should be implemented in product information.
• Communicate drug-related risk and effectiveness data to healthcare personnel and lay persons.

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 and Physiology 3
• 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, which is 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 Studieløp for farmasøyter med mastergrad fra land utenfor EU/EØS:

• FARM4910K – Farmakoterapi og samfunnsfarmasi med fokus på norske terapitradisjoner og norske forhold
• FARM4920K – Fra virkestoff til ferdig formulering med fokus på avanserte legemiddelformer
• FARM4930K – Kvalitetssikring ved produksjon og klinisk utprøvning 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, which is required for students at the 5-year Master`s Programme in Pharmacy.

Lectures, internship at pharmaceutical company, student-active teaching, including computer lab and discussion groups.

• 10 hours lectures (the introductory lecture is compulsory)
• 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 (compulsory)

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.

• Final written exam, which counts 100% towards the final grade.

This course has compulsory exercises and activities that must be approved before you can sit the final 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.

This course offers both postponed and resit of examination. Read more:

• Illness at exams / postponed exams
• Withdrawal during an examination / Resitting an examination