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Department of Pharmacy & Pharmacology, Unit Catalogue 2011/12

PA50296: Drug safety surveillance

Click here for further information Credits: 6
Click here for further information Level: Masters UG & PG (FHEQ level 7)
Click here for further information Period: Modular (no specific semester)
Click here for further information Assessment: CW50EX25OR25
Click here for further information Supplementary Assessment: Supplementary assessment information not currently available (this will be added shortly)
Click here for further information Requisites:
Click here for further information Description: Aims:
To acquire and demonstrate knowledge of, and competency in, the surveillance of the safety of medicines during all stages of development and clinical use, with particular emphasis on the choice, application and analysis of appropriate surveillance methods, on the principles of international regulatory reporting requirements, on the timely revisions of product information and practical methods for managing risk to patients and clinical trial participants.

Learning Outcomes:
On completion of this unit participants will be able to:
* Describe the key regulatory requirements for pharmacovigilance, both in the major (International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use [ICH]) regions and locally, and their historical background.
* Carry out all medical assessments required to meet the requirements for drug safety reporting both at the level of the individual patient (case report) and aggregate report.
* Describe spontaneous reporting and signal detection methodologies, to critically appraise the results of pharmacoepidemiological studies and identify the most appropriate methods for investigating drug safety concerns.
* Assess critically medically adverse event / adverse drug reaction reports as part of causality assessment.
* Describe the principles and methods of evaluation of risk and benefit balance and to apply the principles and methods of managing risk to patients and clinical trial subjects to a simulate drug safety concern.
* Recognise and distinguish the variety of regulatory actions possible to address concerns about patient safety.
* Recognise the importance of communication of safety issues, the variety of formats required to meet audience needs, and contribute to the development of such communications.
* Establish a crisis management team in response to a drug safety concern, recognising the key functional areas to be represented and their roles and responsibilities.
* Identify and critically discuss areas of progress, likely major advances and future challenges in drug safety and pharmacovigilance.


* Conduct of medical assessments for drug safety
* Communication skills (oral and written)
* Team working.

Course content will be delivered by face to face teaching sessions, practical exercises and online through interactive tutorials, videos and podcasts, presented via the course virtual learning environment, Moodle. Topics to be covered:
* Introduction to pharmacovigilance
* Pre-marketing safety surveillance
* Pharmacovigilance in clinical trials
* Post-marketing safety surveillance regulation
* Principles of causality assessment
* Ethics and pharmacovigilance
* Definitions in pharmacovigilance
* Qualified person in pharmacovigilance
* Medication errors
* Product quality complaints
* Documentation in pharmacovigilance
* Assessing post-marketing case reports
* Spontaneous reporting processes: MHRA (UK), EMEA (Europe), FDA (USA), and PMDA (Japan)
* Signal generation
* Prioritising signals and taking action
* Introduction to pharmacoepidemiology
* Drug utilisation studies
* Cohort studies
* Analysis of cohort studies
* Measures of disease frequency
* Critical appraisal of cohort studies
* Case-control studies
* Analysis of case-control studies
* Bias in pharmacoepidemiology
* Confounding
* Critical appraisal of case-control studies
* Principles of risk: benefit assessment
* Risk management and risk mitigation plans
* Taking action (risk management)
* Crisis management.
Click here for further informationProgramme availability:

PA50296 is Optional on the following programmes:

Department of Pharmacy & Pharmacology
  • TSPA-ADT16 : Modular Programme in Advanced and Specialist Practice (Distance Learning)
  • TSPA-ADM16 : MSc Advanced and Specialist Healthcare Practice (Distance Learning)
  • TSPA-ADC16 : PG Cert Advanced and Specialist Healthcare Practice (Distance Learning)
  • TSPA-ADL16 : PG Dip Advanced and Specialist Healthcare Practice (Distance Learning)

NB. Programmes and units are subject to change at any time, in accordance with normal University procedures.