Overview
This training course, considered by many experts as one of the pillars of medical training in pharmacovigilance, focuses on how to use clinical knowledge in the assessment, evaluation and management of selected Adverse Drug Reactions (ADRs). ADRs of the main systems/organs will be presented and explained by the expert in order to provide tools to better understand and manage the serious reactions in clinical trials a well as in post authorisation.
A clinical pharmacology approach is needed for the identification, labelling and understanding of ADR mechanisms. It can also help assess the probability that a medicinal product may have played a role in the occurrence of an adverse event. This is particularly useful for the first 2 or 3 cases of serious reactions occurring during clinical trials when important decisions must be taken regarding a new drug under development.
The approach presented in this training course will take into consideration the conclusions of international or national consensus meetings on adverse drug reactions.
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