Entry requirements

180 credits within pharmacy, pharmaceutical science, medical science, veterinary medical science, biomedicine, science or technology, including biomedical courses such as pharmacology or toxicology. All applicants need to verify English language proficiency.

Learning outcomes

After the course the student should be able to:

-

- apply basic concepts in pharmacovigilance

- explain common mechanisms of adverse drug reactions in major organ system

-  describe how preclinical studies are conducted to evaluate safety of drug candidates

-  explain the role of preclinical studies for further development of drug candidates into clinical trials

- describe Life cycle management of approved medicinal products in providing safe and effective medicinal products

- explain roles of regulatory authorities and pharmaceutical companies in managing reports of adverse drug reactions

-   describe the evaluation of the safety of drug candidates administered to humans for the first time

- analyze the process of drug recalls due to safety issues

- write scientific texts in proper English

Content

The course covers benefit-risk assessment of medicinal products. The course consists of two main parts: preclinical safety assessment of medicinal products and basic pharmacovigilance. Hence, the students will learn how the experimental studies conducted both in-vivo and in vitro are evaluated to identify potential safety risks of drug candidates before their advances to human clinical trials. It also covers how pharmacovigilance plays a critical role in ensuring patient safety by identifying unexpected or rare adverse effects. These two parts are integrated with each other and are examined both individually and in group by a number of oral and written assignments.

Instruction

This part-time online course (50%) is conducted in English and is designed to equip students with the essential skills for gathering, analyzing, and proficiently communicating information regarding benefits and potential risks associated with medicinal products. All participants must have access to a computer with a stable internet connection and the requisite equipment. The course comprises of both individual and group assignments. The individual assignments consist of final examination, written assignment and quizzes. 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 written assignment (1.5 credits), quizzes (2.5 credits) and webinars (2 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 regulations

Substitutes and corresponds to 3FX011 Preclinical safety evaluation and pharmacovigilance.

Because of overlapping course content, Preclinical safety evaluation and pharmacovigilance

(3FX011 or 3FX211) and the course Adverse drug reactions and pharmacovigilance (3FX200) must not be included in the same degree.