Syllabus for Preclinical Safety Assessment and Pharmacovigilance

Preklinisk säkerhetsvärdering och farmakovigilans

Syllabus

  • 7.5 credits
  • Course code: 3FX211
  • Education cycle: Second cycle
  • Main field(s) of study and in-depth level: Pharmaceutical Sciences A1N, Drug Management A1N, Drug Discovery and Development A1N

    Explanation of codes

    The code indicates the education cycle and in-depth level of the course in relation to other courses within the same main field of study according to the requirements for general degrees:

    First cycle

    • G1N: has only upper-secondary level entry requirements
    • G1F: has less than 60 credits in first-cycle course/s as entry requirements
    • G1E: contains specially designed degree project for Higher Education Diploma
    • G2F: has at least 60 credits in first-cycle course/s as entry requirements
    • G2E: has at least 60 credits in first-cycle course/s as entry requirements, contains degree project for Bachelor of Arts/Bachelor of Science
    • GXX: in-depth level of the course cannot be classified

    Second cycle

    • A1N: has only first-cycle course/s as entry requirements
    • A1F: has second-cycle course/s as entry requirements
    • A1E: contains degree project for Master of Arts/Master of Science (60 credits)
    • A2E: contains degree project for Master of Arts/Master of Science (120 credits)
    • AXX: in-depth level of the course cannot be classified

  • Grading system: Fail (U), Pass (G), Pass with distinction (VG)
  • Established: 2016-05-26
  • Established by:
  • Revised: 2022-06-09
  • Revised by: The Educational Board of Pharmacy
  • Applies from: Autumn 2023
  • Entry requirements:

    University education equivalent to at least 180 credits (i.e. three years of full-time studies) in pharmacy, pharmaceutical science, medical science, veterinary medical science, biomedicine, science or technology; previous studies should include biomedical courses such as pharmacology or toxicology. All applicants need to verify English language proficiency. This is normally verified by means of an internationally recognised test such as TOEFL or IELTS.

  • Responsible department: Department of Pharmaceutical Biosciences

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.

Reading list

Reading list

Applies from: Autumn 2023

Some titles may be available electronically through the University library.

Literature

Waller, Patrick. An introduction to pharmacovigilance Chichester, UK: Wiley-Blackwell, Latest edition Mandatory

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 Studium.

Supplementary textbooks

  • Cobert, Barton L. Cobert's manual of drug safety and pharmacovigilance

    2nd ed.: Sudbury, Mass.: Jones & Bartlett Learning, c2012

    Find in the library

  • Talbot, J. C. C.; Aronson, Jeffrey K.; Stephens, M. D. B. Stephens' detection and evaluation of adverse drug reactions : principles and practice

    6th ed.: Chichester, West Sussex, UK: John Wiley & Sons, 2012

    Find in the library

  • Leong, James.; Salek, Sam.; Walker, Stuart. Benefit-Risk Assessment of Medicines : The Development and Application of a Universal Framework for Decision-Making and Effective Communication

    Cham: Springer International Publishing, 2015.

    Find in the library

  • Andrews, Elizabeth B.; Moore, Nicholas Mann's pharmacovigilance

    Third edition.: Chichester, West Sussex, UK: John Wiley & Sons Inc., 2014.

    Find in the library