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Department of Pharmacy & Pharmacology, Unit Catalogue 2011/12

PA30264: Spontaneous reporting and pharmacoepidemiology

Click here for further information Credits: 6
Click here for further information Level: Honours (FHEQ level 6)
Click here for further information Period: Semester 2
Click here for further information Assessment: CW 100%
Click here for further information Supplementary Assessment: Like-for-like reassessment (where allowed by programme regulations)
Click here for further information Requisites: Students completing this unit will normally be expected to complete a PA40042 year 4 project in the same subject area.
Click here for further information 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.
Click here for further informationProgramme availability:

PA30264 is Optional on the following programmes:

Department of Pharmacy & Pharmacology
NB. Programmes and units are subject to change at any time, in accordance with normal University procedures.