Drug Safety Research Unit

Risk Benefit Assessment in Pharmacovigilance

Practical Information

Commencing Date:
Farehem United Kingdom

Teaching Methodology:
Blended Learning

European Fees:
1190 British Pound (GBP)
Scholarship Possibilities:

Course Contact

Drug Safety Research Unit

University Accreditation: No

Individual Course


Introduction Risk benefit assessment is vital during the whole life cycle of products. For each medicine there is a balance between risk and benefit, but the perspective of different stakeholders (regulator, marketing authorisation holder, academic, patient, or prescriber) may vary. This course provides solid practical foundations which enable delegates to explore the relationship between risk and benefit, plus review the integration of appropriate strategies within risk management plans. Attendance at this course can be used as part of the training required for Higher Medical Training (HMT) and Pharmaceutical Medicine Specialty Training (PMST). Aims - To develop knowledge and understanding of the principles of risk benefit assessment, plus methods available for quantitative risk - benefit analysis and their practical application in decision making - To critically analyse factors associated with drug safety signals, the appropriate application of signal detection methodology and its contribution to safety monitoring and risk management - To critically appraise with current regulatory legislation and guidelines relevant to risk management plans and recognise and justify their importance in helping ensure patient safety - To analyse and review relevant documents for communicating risk benefit (including patient information leaflets, data sheets and safety alerts) - To analyse recent challenges faced by regulators and marketing authorisation holders, critically review lessons learnt and outline future strategies for optimising pharmacovigilance activities to prevent withdrawal from the market This course is offered as a stand alone short course, with CPD accreditation from the Faculty of Pharmaceutical Medicine, and as part of our postgraduate programme in pharmacovigilance in collaboration with the University of Portsmouth.


On completion of this course delegates should be able to: - Analyse and evaluate a safety signal - Undertake a risk benefit analysis of a newly marketed medicinal product, make and justify appropriate recommendations for communicating the updated information - Differentiate between the various regulatory actions possible to address drug safety signals - Recommend and justify options for crisis management of a safety signal

IMI Standards

  • A predefined set of teaching objectives, leading to defined learning outcomes
  • Assessment of the students' achievement in accordance with the agreed learning outcomes of the training offered
  • A system for collecting, assessing and addressing feedback from learners, teachers, technical / administrative staff and programme / course / module managers
  • Availability of appropriate and regularly reviewed reference material (e.g. published articles, links, book chapters, scripts, etc)
  • Defined and transparent admission criteria
  • Quality assurance of teaching staff
  • Regular review of the QA/QC process and demonstration that the training is further developed in light of this review
  • The facilities, infrastructure, leadership and competences available for the support of student learning
  • University accreditation OR a system for approving, monitoring and reviewing the training offered