General provisions

Because of overlapping course content, Preclinical safety evaluation and pharmacovigilance

(3FX011) 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.

Entry requirements

At least 120 credits within the Bachelor of Science Programme in Pharmacy or 150 credits within the Master of Science Programme in Pharmacy, of which 60 credits must be in the field of pharmaceutical biosciences (including the courses: toxicology, drug metabolism and safety evaluation, pharmacology, physiology, molecular genetics and biochemistry). Students admitted to the Master programme in drug development or the Master programme in drug management fulfil the requirements to take the course.

For the optional course 150 credits are required, including 60 credits in biomedicine, medicine or pharmaceutical biosciences (e.g. biochemistry, physiology, cell biology, pharmacology and toxicology) and at least 10 credits in pharmacology, or equivalent knowledge within the subject area.

All applicants need to verify English language proficiency. This is normally attested by means of an internationally recognised test such as TOEFL or IELTS, see link http://www.uu.se/en/education/application/requirements/

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 the course start, seminars 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. Each student has the right to six examinations i.e. one examination and five re-examinations.