As well as providing a firm grounding on key aspects of global and European clinical pre-and-post-marketing safety regulatory requirements, the course covers updates on pharmacovigilance legislation. It also covers the latest news on the international harmonisation and standardisation activities in pharmacovigilance.
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The key topics include:
definitions and methods in pharmacovigilance
regulatory aspects in pharmacovigilance and practical examples
diagnosis and management of adverse drug reactions
signal detection and signal management
Who should attend
The course, delivered by the Medicines and Healthcare products Regulatory Agency (MHRA) and Develop Innovate Advance (DIA), is for professionals involved in pharmacovigilance and qualified persons for pharmacovigilance (EU QPPV) as well as those involved in: