Main field(s) of study and in-depth level:
Drug Discovery and Development A1F,
Drug Management A1F
Fail (U), Pass (G), Pass with distinction (VG)
The Educational Board of Pharmacy
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 attendance of all courses in semesters 1-7.
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.
Participating unit: the Uppsala Monitoring Centre (UMC) within WHO.
On completion of the course the student should be able to:
Search, compile, analyse and evaluate reports about adverse drug reactions in scientific literature and databases.
Explain the importance of pharmacogenomics for individual variation in adverse drug reactions.
Analyse methods for pharmacovigilance.
Analyse and assess warnings, risk management and risk communication about adverse drug reactions.
Analyse and assess the effects and safety of drugs.
Give an account for pharmacovigilance from a regulatory perspective.
Write scientific and popular text in proper English.
The course focus on how to compile, analyse and assess the effect and safety of drugs as well as pharmacovigilance. Examination is based on written tests and assignments. During the course, the student will train oral and written presentation in groups and individual written presentation.
The course is Internet-based, and the teaching is given as half-time studies. All teaching is given in English. Strong emphasis is placed at the student's ability to acquire, process and communicate scientific material about the effect and safety of drugs. A web-based learning management platform will be used in the teaching and for communication between participants and teacher. Mandatory parts are assignments and written essay assignment. The course contains no compulsory physical meetings. This assumes that the participants have access to an Internet-connected computer and additional equipment according to instructions from the department.
Examination takes place at the end of the course. Passing the course requires, an approved test (examination code), passed results of web seminars (examination code) and written advanced assignment (examination code). A chance to carry out a failed compulsory part can be arranged only at the next course occasion 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.
Mandatory reading material
Selected scientific publications (ca 100 pages) and an individual selection of scientific publications available on-line in the university library with links from the Student Portal.
Talbot, J. C. C.;
Aronson, Jeffrey K.;
Stephens, M. D. B.
Stephens' detection and evaluation of adverse drug reactions : principles and practice
Chichester, West Sussex, UK:
John Wiley & Sons,