MSc Pharmaceutical Industrial Advanced Training (PIAT) / Course details

Year of entry: 2020

Course unit details:
Pharmacovigilance - post marketing surveillance

Unit code PHAR72070
Credit rating 15
Unit level FHEQ level 7 – master's degree or fourth year of an integrated master's degree
Teaching period(s) Variable teaching patterns
Offered by Pharmacy
Available as a free choice unit? No

Overview

This unit provides an introduction to pharmacovigilance including key definitions and the nature and burden of adverse drug reactions (ADRs). It covers safety monitoring in clinical trials, what ADRs this will detect and its limitations. It goes on to look at the methods for post-marketing surveillance, introduces patient risk management and relevant ICH Guidelines and CIOMS reports.

 

 

Aims

The unit aims to:

Provide a clear understanding of adverse drug reactions (ADRs) and Pharmacovigilance and the theory, practice and regulations concerning safety monitoring and evaluation in clinical trials and for marketed products.

 

Learning outcomes

At the end of the unit, the student should have acquired sufficient knowledge and skills:
 
• To understand the key terms used in pharmacovigilance
• To understand the nature, mechanisms of and risk factors for ADRs, the key body systems and organs involved and the burden of ADRs in practice and how they can be avoided
• To gain an insight into the concept of risk/benefit, causality assessment and the hierarchy of evidence
• To understand the purpose, practice and limitations of monitoring safety in clinical trials
• To understand the differences in monitoring and evaluating safety with marketed products, the techniques available and their strengths and weaknesses
• To appreciate special considerations in monitoring the safety of biotechnology products, vaccines and herbal medicines
• To understand the principles of patient risk management
• To understand the regulatory basis of pharmacovigilance (ICH), some of the EU Pharmacovigilance legislation and the CIOMS initiatives

Teaching and learning methods

The module itself contains quite a lot of information but is only a brief introduction to the subject. The student is directed to other sources of information by links to websites, references and a short bibliography, particularly Stephens’ Detection and Evaluation of Adverse Drug Reactions, 6th edition, 2012. References are cited in the text, students do not have to read them all but may find them a useful source of further information. The bibliography is suggested reading for the module, some of the books listed are likely to be available in the student’s place of work or the University library. The bulk of the work will be working through the module and reading plus completion of the exercises (8 out of 12 questions). The questions are aligned with the sort of tasks commonly undertaken by those involved in designing and running safety aspects of clinical trials and undertaking post-marketing surveillance.
 
 

Assessment methods

Method Weight
Written exam 70%
Written assignment (inc essay) 30%

Feedback methods

Assignment - Marks and feedback sent by email within 15 working days

Exam - Marks and feedback published after exam board

Study hours

Scheduled activity hours
Assessment written exam 2
Independent study hours
Independent study 148

Teaching staff

Staff member Role
John Talbot Unit coordinator

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