Module Objectives
The module covers the safety and risk issues one must address to ensure patients receive safe drugs. This module will give students a working knowledge of all aspects of drug safety monitoring and risk management and be able to predict and analyse drug interactions, and recognise the implications for prescribing and product licence. The student will also be familiar with pharmacovigilance best practice, including monitoring strategies and action plans and be fully cognisant of regulatory reporting requirements.
Intended Module Learning Outcomes
Appreciate the effect on patient safety and a products licence by the different types of adverse events/reactions.
Identify the key safety reporting requirements, according to the type of adverse event/reaction, (in clinical research or in commercial products).
Construct and evaluate benefit/risk assessments throughout the lifecycle of a medicine, with reference where applicable to issues around pre and post market authorisation.
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