Drug Safety and Pharmacovigilance
Course, Master's level, 3FX224
Autumn 2023 Autumn 2023, Flexible, 50%, Distance learning, English
- Location
- Flexible
- Pace of study
- 50%
- Teaching form
- Distance learning
- Number of mandatory on-campus meetings
- 0
- Number of optional on-campus meetings
- 0
- Instructional time
- Mixed
- Study period
- 30 October 2023–14 January 2024
- Language of instruction
- English
- 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.
- Selection
-
Higher education credits (maximum 285 credits)
- Fees
-
If you are not a citizen of a European Union (EU) or European Economic Area (EEA) country, or Switzerland, you are required to pay application and tuition fees.
- Application fee: SEK 900
- First tuition fee instalment: SEK 18,125
- Total tuition fee: SEK 18,125
- Application deadline
- 17 April 2023
- Application code
- UU-38501
Admitted or on the waiting list?
- Registration period
- 23 October 2023–6 November 2023
- Information on registration.
Autumn 2023 Autumn 2023, Flexible, 50%, Distance learning, English For exchange students
- Location
- Flexible
- Pace of study
- 50%
- Teaching form
- Distance learning
- Number of mandatory on-campus meetings
- 0
- Number of optional on-campus meetings
- 0
- Instructional time
- Mixed
- Study period
- 30 October 2023–14 January 2024
- Language of instruction
- English
- 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.
Admitted or on the waiting list?
- Registration period
- 23 October 2023–6 November 2023
- Information on registration.
About the course
This is a continuation course based on the same format as the introductory course (Preclinical Safety Assessment and Pharmacovigilance) but a more comprehensive textbook will be used. We will discuss the principles of benefit/risk profiling of drugs and the safe use of medicines. The course is suitable for those who want to work with adverse drug event reporting and drug safety.
The course will focus on
- risk management and communication
- adverse event reporting and methods in pharmacovigilance
- the importance of genetic variation for adverse drug reactions
- serious adverse drug reactions
- risk/benefit profiling of pharmaceutical drugs especially biologicals and vaccines as well as pharmaceuticals and genetic variation.
This course does not cover the detailed pharmacovigilance guidelines or regulations set up by EMA and FDA or the web-based pharmacovigilance tools set up by these agencies. Furthermore, the course will not cover the detailed regulations for adverse event reporting within pharmaceutical companies.
Outline for distance course: The course is entirely web-based and contains no compulsory campus meetings. Lectures are recorded and organised as video/audio sessions and are available on a web-based teaching platform. The students are offered supervised studies via the same teaching platform. This platform is also used for individual assignments, group exercises and discussions. Some of these assignments and exercises are mandatory and the participants are offered general or individual feedback on these moments. The participants and teachers communicate via the website and via email. A forum for discussion is also available. Examination will be in the form of web-based tests or individual assignments. In order to participate in this course you must have access to a computer with a rapid internet connection and headset with microphone.
The course is given in collaboration with the Uppsala Monitoring Centre (UMC). UMC is responsible for the management of the WHO Programme for International Drug Monitoring and the WHO Global ICSR Database.