Syllabus for Preclinical Safety Assessment and Pharmacovigilance

Decisions and guidelines

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.

The course is given in collaboration with the Uppsala Monitoring Centre (UMC) which is a unit within the WHO.

Learning outcomes

After the course the student should be able to:

- describe common types of adverse drug reactions

- describe how candidate drugs can be preclinically tested to demonstrate possible harmful effects

- describe how the pharmaceutical industry and medical agencies manage reports of adverse drug reactions

- explain principal mechanisms for adverse drug reactions in major organ systems

- explain common causes for individual variation of adverse drug reactions

- explain and analyse pharmacovigilance of adverse drug reactions

- analyse preclinical safety studies of candidate drugs given for the first time to humans

- search for and analyse reports of adverse drug reactions in scientific literature and databases

- analyse risk management and risk communication in connection to withdrawal of pharmaceutical drugs from the market due to adverse reactions

- discuss strategies that can be used to reduce the occurrence of adverse drug reactions

- analyse benefits versus risks of pharmaceutical drugs

- write a short essay in proper English language with a scientific vocabulary

Content

The course covers benefits-risk assessment of drugs. The course consists of two main parts: preclinical safety assessment of drugs and pharmacovigilance. These two parts are integrated with each other and are examined in one written exam.

Instruction

The course is a web-based part time course (50%) and all teaching will be in English. Emphasis is placed on the student's ability to collect, process and communicate information about the benefits and risk of pharmaceutical drugs. Web-based teaching platforms will be used for communication between students and teachers.

Mandatory elements of the course are assignments and a minor written essay. The course is completely web-based and has no face-to-face meetings. This requires that all participants have access to a computer with Internet connection and equipment according to instructions from the department.

Assessment

The final examination takes place at the end of the course. To pass the course both the final examination (examination code) and the compulsory assignments (examination codes) must be passed in order to pass the whole course. Failed compulsory assignments can earliest be supplemented during the next course and only in case of a vacancy.

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.