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Advanced Curriculum in Higher Medical Training in Pharmaceutical Medicine

DSRU is working with the Faculty of Pharmaceutical Medicine (PFM) to deliver the Drug Safety Surveillance Higher Medical Training Module for which three courses have been designed. They are 'Back to Basics in Pharmacovigilance', 'Introduction to Pharmacoepidemiology' and 'Risk Benefit Assessment in Pharmacovigilance'. Each two day course will deliver theory and experiential learning together with assessments which have been reviewed by the Board of Examiners of the FPM. The courses are accredited by the FPM and each one can be used as part of the training required to obtain the Certificate of Completion of Specialist Training awarded by the Post Graduate Medical Education and Training Board (PMETB).

Although priority will be given to Higher Medical Training (HMT) candidates, these two day modules will also be open for non HMT participants (who will not undertake assessments). Full information on the courses and assessments will be provided to those who register.

We recommend attending these courses in the following order, 'Back to Basics in Pharmacovigilance', an 'Introduction to Pharmacoepidemiology', and Risk Benefit Assessment in Pharmacovigilance', however if the dates are not convenient then please contact us.


Back to Basics in Pharmacovigilance

Course objectives

  • Historical aspects and evolution of drug safety
  • Regulatory aspects, including the Clinical Trial Directive and PDUFA III
  • International Conferences of Harmonisation
  • Collecting and reporting drug safety information
  • Pharmacovigilance planning


    • Dates and venue
    11/12 March 2009 & 9/10 September 2009
    Course to be held in the Southampton area



    Introduction to Pharmacoepidemiology

    Course objectives
    By the end of the course, delegates will have:
  • An awareness of the scope and purposes of pharmacoepidemiology
  • An understanding of the principal study methods and basic statistical tools
  • Knowledge of the key data resources
  • Practical experience in interpreting pharmacoepidemiological data
  • Gained information on opportunities for further training


    • Dates and venue
    15/16 July 2009
    Solent Hotel, Rookery Avenue, Whiteley, Fareham, PO15 7AJ, Hampshire



    Risk Benefit Assessment in Pharmacovigilance

    Course objectives
  • Principles of risk: benefit assessment and management
  • Familiarity with CIOMS IV
  • Evaluating signals
  • Reporting and summarising safety data at registration and for the PSUR
  • Variations, urgent safety restrictions, licence suspension and withdrawal
  • European procedures and PDUFA III
  • SPCs and PILs
  • Crisis management


    • Dates and venue
    14/15 October 2009
    Solent Hotel, Rookery Avenue, Whiteley, Fareham, PO15 7AJ, Hampshire