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PA30264: Drug safety

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: Honours (FHEQ level 6)
Further information on teaching periods Period: Semester 2
Further information on unit assessment Assessment Summary: CW 100%
Further information on unit assessment Assessment Detail:
  • Reports (CW 60%)
  • Poster Presentation (CW 10%)
  • Project Protocol (CW 30%)
Further information on supplementary assessment Supplementary Assessment: Like-for-like reassessment (where allowed by programme regulations)
Further information on requisites Requisites: Students completing this unit will normally be expected to complete a PA40042 year 4 project in the same subject area.
Further information on descriptions Description: Aims:
To develop the knowledge and understanding of the processes involved in evaluating drug safety.

Learning Outcomes:
By the end of this unit the student will be able to:
* Demonstrate knowledge and understanding of existing spontaneous reporting systems and ways to analyse safety signals arising from them;
* Demonstrate knowledge and understanding of study designs in pharmacoepidemiology and their suitability depending on the safety question to be addressed;
* Demonstrate an understanding of and capacity to carry out data analysis and sample size requirements;
* Critically evaluate randomised controlled clinical trials as well as drug safety studies;
* Integrate the information available from clinical trials and pharmacoepidemiology to develop an overall understanding of a drug's risk-benefit profile;
* Develop proposals for risk management plans;
* Demonstrate self-direction and continue to advance their understanding to high levels.


* Handling information (taught / facilitated)
* Critical appraisal (taught / facilitated / assessed)
* Analytical thinking (taught / facilitated / assessed)
* Lateral thinking (taught / facilitated / assessed)
* Improving learning and performance (taught / facilitated)
* Problem solving (taught / facilitated / assessed).

An introduction and overview of spontaneous reporting and pharmacoepidemiology and their role in a product's life cycle; various methods of spontaneous reporting systems and ways to analyse the data; study designs in pharmacoepidemiology; statistical analysis; crisis management, risk management plans, and critical appraisal of studies. This will all be addressed from various angles, i.e. the regulatory authorities, pharmaceutical industry, and academia. The course is hands-on in the sense students will be expected to analyse potential signals, propose study designs for follow-up of such signals as deemed necessary, critically appraise published studies and safety signals produced from case series, develop risk management plans for products to be introduced on the market, and develop crisis management proposals.
Further information on programme availabilityProgramme availability:

PA30264 is Optional on the following programmes:

Department of Pharmacy & Pharmacology
* 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.