EU Regulations and Guidelines in Pharmacovigilance

In 2012, new EU pharmacovigilance regulations and guidance became effective in Europe replacing the former Volume 9A rules governing Medicinal Products in the European Union. They describe the structures, requirements, procedures, roles and activities of the various stakeholders. These are detailed for the collection, verification, presentation and interpretation of adverse reports to exchange information within the EU, to monitor safety products on the market in the EU, to proactively manage safety concerns and to guarantee continuous surveillance of the benefit risk profile of such drugs. Our EU Regulations and Guidelines for Pharmacovigilance course will cover the development and current requirements of Good Pharmacovigilance Practices (GVP). The course will also cover other aspects of the current legislation and will provide delegates with a professional working knowledge of EU Pharmacovigilance requirements and an overview of the processes and procedures necessary to ensure compliance. Consideration will also be given to the effects on pharmacovigilance requirements of the UK leaving the EU.

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