Preclinical Safety Assessment and Pharmacovigilance, 7.5 credits

Academic year 2021/2022

  • Autumn 2021, Mixed, 50%, Distance learning

    Start date: 30 August 2021

    End date: 31 October 2021

    Application deadline: 15 April 2021

    Application code: UU-38505 Application

    Language of instruction: English

    Location: Flexible

    Selection: Higher education credits (maximum 285 credits)

    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 e-mail. 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 Internet connection, headset with microphone and programs such as Adobe Flash/Connect have to be installed.

    Number of mandatory meetings: 0

    Number of voluntary meetings: 0

    Registration: 30 July 2021 – 30 August 2021

  • Spring 2022, Mixed, 50%, Distance learning

    Start date: 17 January 2022

    End date: 23 March 2022

    Application deadline: 15 October 2021

    Application code: UU-88505 Application

    Language of instruction: English

    Location: Flexible

    Selection: Higher education credits (maximum 285 credits)

    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 e-mail. 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 Internet connection, headset with microphone and programs such as Adobe Flash/Connect have to be installed

    Number of mandatory meetings: 0

    Number of voluntary meetings: 0

    Registration: Please contact the department.

Entry requirements: 180 credits in pharmacy, pharmaceutical science, medical science, veterinary medical science, biomedicine or chemical engineering focusing on pharmaceuticals. The education should include biomedical courses such as physiology, biochemistry, cell/molecular biology, and must include a course in pharmacology or toxicology. All applicants need to verify English language proficiency equivalent to the course English 6 in the Swedish secondary school.

For optional course within the Master of Science Programme in Pharmacy is 150 credits within the programme required. Passed grade in courses in toxicology, drug metabolism and safety evaluation and pharmacology is required. All courses semester 1-7 must be attended.
Admitted to the Master's Programme in Drug Management or to the Master's Programme in Drug Discovery and Development.

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 or tuition fees. Formal exchange students will be exempted from tuition fees, as well as the application fee. Read more about fees.

Application fee: SEK 900

Tuition fee, first semester: SEK 18,125

Tuition fee, total: SEK 18,125

Please note: We appreciate that you are considering to apply to this course. Please note that you need a course in pharmacology or general toxicology in order to be eligible.

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.

About the course

This introductory course provides a concise overview on principles of preclinical safety assessment and pharmacovigilance. We will discuss the assessment of drug candidates, risk/benefit profiling of drugs and the safe use of medicines. The course is suitable for those who want to work with preclinical toxicity testing or adverse drug reaction reporting and pharmacovigilance.

The course will focus on principles of

  • Mechanisms of toxicity and adverse drug reactions
  • Preclinical toxicity testing
  • Phase 1 clinical trials
  • Drug recalls
  • Risk/benefit assessments of drug candidates and pharmaceutical drugs
  • Pharmacovigilance
We will discuss the safety of drug candidates and pharmaceutical drugs based on toxicity testing, clinical trials as well as on the general use on the market. Please note that the course will not cover the detailed regulatory toxicity testing and pharmacovigilance guidelines and regulations set up by medicine agencies such as 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.

More information

Contact

Department of Pharmaceutical Biosciences

Biomedicinskt centrum BMC, Husargatan 3

Box 591, 751 24 UPPSALA

Eva Brittebo

Email: eva.brittebo@farmbio.uu.se