• Darren Wogman

Feedback for 'Three core components of the EU drug safety system'

“Explain and critically evaluate how the three core components of the EU drug safety system operate[…and how] a bio-pharmaceutical company use[s] the system to minimise the risks of harm from its medicines.”

This is feedback for this assignment

Assessor 1 comment:

This is a generally good assignment. You have omitted to address Part B of the assignment, which does have a specific topic for discussion and cannot be extrapolated for Part A. Your have described well the 3 component parts of ICSR, Signal detection and PASS and have engaged in a critical evaluation and discussion of them. It is possible to disagree with some of the assumptions and facts presented, but overall you have demonstrated an understanding of the workings of these PV components, and hinted at their contribution to the greater PV system. It would have been good to see more discussion of the interactions of the three components and their integration into the wider PV system, perhaps to illustrate how the 'whole is (or is not) greater than the sum of the parts' - if the parts are deficient, e.g. ICSRs, or signal detection, what does this mean for the whole PV 'enterprise'? This would then have been enhanced by Part B illustrating how companies (MAHs) utilise the components parts of the system, and integrate with wider aspects, including national and international regulatory systems to minimise the risk of harm from its medicines to patients; this could have included the company's own approach to risk management, namely the RMP (Risk Management Plan) and how they use this tool to manage life-cycle risks and risk minimisation. You did not make it this far!

References good and high-level, illustrating the wide reading you have done to address this assignment.

Assessor 2 comment:

Your writing style is clear and concise. Your introduction nicely lays out the essay, but towards the end I get the sense that it was a bit more rushed than usual (spelling/grammar errors etc.), plus you did not attempt part B, despite having been clearly aware of it from its' brief mention in the introduction.

The examples that you have given for each of the PV components are well chosen to illustrate their function, and aid in their critical analysis.

The essay could have been improved by relating each of the PV components to each other, and of course addressing Part B.

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