Syllabus for Drug Safety and Pharmacovigilance

Läkemedelssäkerhet och farmakovigilans

Syllabus

  • 7.5 credits
  • Course code: 3FX224
  • Education cycle: Second cycle
  • Main field(s) of study and in-depth level: Drug Discovery and Development A1F, Drug Management A1F
  • Grading system: Fail (U), Pass (G), Pass with distinction (VG)
  • Established: 2016-05-26
  • Established by:
  • Revised: 2019-04-25
  • Revised by: The Educational Board of Pharmacy
  • Applies from: week 31, 2019
  • 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 attendance of all courses in semesters 1-7.
  • Responsible department: Department of Pharmaceutical Biosciences

Decisions and guidelines

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.

Learning outcomes

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.

Content

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.

Instruction

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.

Assessment

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.

Reading list

Reading list

Applies from: week 01, 2020

Literature

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 Student Portal.

  • 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

    Mandatory

supplementary textbooks

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

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

    Find in the library

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

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

    Find in the library

  • Klepper, Michael J.; Cobert, Barton L. Drug safety data : how to analyze, summarize, and interpret to determine risk

    1st ed.: Sudbury, MA: Jones and Bartlett Publishers, c2011

    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.

    Table of Contents / Abstracts

    Find in the library