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PA50296: Drug safety surveillance

Follow this link for further information on academic years Academic Year: 2015/6
Further information on owning departmentsOwning Department/School: Department of Pharmacy & Pharmacology
Further information on credits Credits: 6
Further information on unit levels Level: Masters UG & PG (FHEQ level 7)
Further information on teaching periods Period: Modular (no specific semester)
Further information on unit assessment Assessment Summary: CW50EX25OR25
Further information on unit assessment Assessment Detail:
  • Assessment detail to be confirmed ( %)
Further information on supplementary assessment Supplementary Assessment: Supplementary assessment information not currently available (this will be added shortly)
Further information on requisites Requisites:
Further information on descriptions 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.
Further information on programme availabilityProgramme availability:

PA50296 is Optional on the following programmes:

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

* This unit catalogue is applicable for the 2015/16 academic year only. Students continuing their studies into 2016/17 and beyond should not assume that this unit will be available in future years in the format displayed here for 2015/16.
* Programmes and units are subject to change at any time, in accordance with normal University procedures.
* Availability of units will be subject to constraints such as staff availability, minimum and maximum group sizes, and timetabling factors as well as a student's ability to meet any pre-requisite rules.