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Pharmacovigilance: The Regulatory Outlook

Pharmacovigilance Team

2012 saw the introduction of good pharmacovigilance practices (GVPs) in the European Union (EU) and since then, the industry has experienced a huge amount of change, including the introduction of the new EudraVigilance system in 2017. The new system, due to be fully implemented in 2019, is a European data processing network and management system designed to allow companies to report and evaluate suspected adverse reactions both during drug development and on an ongoing basis.

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Topics: Good Pharmacovigilance Practices, Eudravigilance, GVP Module VI, ICH E2B(R3), International Conference on Harmonisation (ICH), Regulatory Requirements, Good Clinical Practice (GCP), New Pharmacovigilance Legislation, Safety Database, European Medicines Agency

Compliant with the new Eudravigilance Medicinal Product Dictionary?

Pharmacovigilance Team

With just over a week to go before the Article 57(2) requirements for population of the eXtended Eudravigilance Medicinal Product Dictionary (XEVMPD) become mandatory, the European Medicines Agency (EMA) has today published an updated version of the ‘eXtended EudraVigilance Medicinal Product Report Message (XEVPRM) Frequently Asked Questions & Answers (FAQs)’ document.

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Topics: Pharmacovigilance, Eudravigilance, Medicinal Product Dictionary (XEVMPD), New Pharmacovigilance Legislation, Good Pharmacovigilance Practices, European Medicines Agency

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