Drug Safety Research Unit

Back to Basics in Pharmacovigilance

Practical Information

Commencing Date:
Fareham United Kingdom

Teaching Methodology:
Blended Learning

European Fees:
1190 GBP
Scholarship Possibilities:

Course Contact

Drug Safety Research Unit

University Accreditation: No

Individual Course


Monitoring drug safety is very important to public health. Pharmacovigilance is the science and activities relating to the detection, assessment, understanding and prevention of adverse effects or any other drug-related problems. Those working in pharmacovigilance must have good working knowledge of the principles of drug safety, its regulations and proactive strategies for risk management. This course provides solid practical foundations for those working in drug safety, and an update for experienced staff. This course will be valuable not only to those working directly in pharmacovigilance but to a broad range of staff across the pharmaceutical industry and regulatory authorities. Aims - To provide delegates with a historical perspective of pharmacovigilance - - To explore the principles of causality - - To ensure an understanding of basic terminology and provide definitions of key concepts - - To introduce delegates to current key regulatory requirements, both local and international - - To introduce delegates to the concept of benefit risk in pre-marketing development - - To provide an awareness of the evolution of systems of reporting Programme features - Historical aspects and evolution of drug safety - - Regulatory aspects, including the Clinical Trial Directive and PDUFA III - - International Conferences on Harmonisation - - Collecting and reporting drug safety information - - Pharmacovigilance planning 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 the course delegates should be able to: - Critically appraise the founding principles of pharmacovigilance and landmark cases effecting change to recent drug safety issue - Explain key operational drug safety definitions - Demonstrate good pharmacovigilance practice and locate key sources of information and documentation - Critically discuss issues associated with global pharmacovigilance - Analyse the stages of drug development in terms of drug safety assessment and benefit risk - Critically explain the strengths and weakness of pharmacovigilance reporting systems - Identify and predict future challenges in drug safety and pharmacovigilance

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