Entry requirements

Adverse Drug Reactions and Pharmacovigilance, 7.5 credits, or at least 2.5 credits from Preclinical Safety Assessment and Pharmacovigilance. Within the Master of Science Programme in Pharmacy 150 credits within the programme are also required, as well as participation in all courses in semesters 1-7.

Learning outcomes

On completion of the course the student should be able to:

- explain and apply advanced concepts in pharmacovigilance

- analyze and evaluate the importance of spontaneous reporting and the use of pharmacovigilance databases for safety monitoring of medicinal products

- analyze and evaluate the importance of pharmacogenomics for individual variation in adverse drug reactions

- explain common adverse drug reactions of biological medical products

- compare and evaluate basic regulatory pharmacovigilance activities

- write scientific and popular science texts in proper English

- search, analyze and evaluate reports about adverse drug reactions in scientific literature and pharmacovigilance databases

- analyze how the Pharmacovigilance Risk Assessment Committee (PRAC ) in EMA evaluates safety signals

Content

The course focus on how to compile, analyze and assess the effect and safety of medicines, vaccines and biological products. The course also covers how safety signals are detected, assessed and evaluated using pharmacovigilance databases. Emphasis is placed on the ability of the students to study risks and benefits of medicinal products and the key roles of regulatory authorities in using databases as means for proactive pharmacovigilance strategies to ensure patient safety.

Instruction

This part-time online course (50%) is conducted in English. The course utilizes web-based teaching platforms; hence it is imperative for all participants to have access to a computer with a stable internet connection and the requisite equipments. The course comprises of both individual and group assignments. The individual assignments consist of a final examination, an individual written assignment and other mandatory assignments. Webinars are conducted in randomly assigned groups.

Assessment

The final written examination will be held at the end of the course. To successfully complete the course, students must pass both the final examination (1.5 credits) and all the mandatory assignments i.e an individual written assignment (1.5 credits), webinars (2 credits) and other mandatory assignments (2.5 credits). 

If there are special reasons for doing so, an examiner may make an exception from the method of assessment indicated and allow a student to be assessed by another method. An example of special reasons might be a certificate regarding special pedagogical support from the University's disability coordinator.

Other directives

This is a continuation course to Pre-clinical safety assessment and pharmacovigilance (3FX011 or 3FX211) 7.5 credits and Adverse drug reactions and pharmacovigilance (3FX200 or 3FX201), 7.5 credits.