Drug Safety Research Unit

Pharmacovigilance Planning and Risk Management

Practical Information

Commencing Date:
Southampton 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 A pro-active approach to risk management of drug safety is vital throughout the whole life-cycle of a medicinal product. The aim of this course is to critically explore existing and developing strategies to plan and optimise risk management activities for known and potential risks of a newly approved product. The relationships between pharmacovigilance plans, risk management, pharmacoepidemiology and risk minimisation programmes will be the central theme. Experts will share their personal experiences in managing the risk of bringing new medicines to market, and outline new approaches to mitigating risk and improving decision making. Group interactive sessions will analyse recent 'real-world' challenges faced by marketing authorisation holders and regulators. Aims - To critically appraise the elements of a Risk Management System through evaluation of the relationship between pharmacovigilance and risk management plans - To prepare for construction of Safety Specification and Risk Management Plans through critical evaluation of the latest concepts in tools and strategies for risk assessment and prevention - To critically examine current recommendations and practices of managing risk and analyse the implications for decision-making Programme features: - Current regulation and guidance relevant to global risk management - Safety specification and pharmacovigilance planning - Risk management activities and the drug development programme - Stakeholder perspectives on construction and execution of risk management plans - Workshop to analyse recent challenges in the implementation of risk management plans - Development of best practice techniques - Management of drug safety after reclassification 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 successful completion of this course delegates should be able to: - Critically interpret the purposes of risk management systems in drug safety and the challenges that risk management represents - Plan, prepare and justify Safety Specification and Risk Management Plans - Demonstrate a critical awareness of models for safety agreements and have basic knowledge and skills required to proactively manage the development and execution of a safety agreement with a partner

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