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Development Update Safety Report

According to ICH guideline E2F (Step 5) on Development Safety Update Reports (DSURs) already implemented since 2011, companies...

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Development Safety Update Report (DSUR)

In September 2010, the International Conference Harmonisation developed the ICH E2F Guideline for the Development Safety...

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Periodic Benefit-Risk Evaluation Report (PBRER)

According to European Medicaments Agency (EMA) guidelines, already implemented since 2012; Marketing Authorization Holders...

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Risk Management Plan: GVP Module V

European Medicines Agency published Module V of Good Vigilance Practices in 2012 and it was later revised in April 2014....

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Pilot extension in EVDAS

The European pharmacovigilance legislation requires marketing authorization holders (hereinafter MAHs) to continuously monitor...

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GVP Módulo II: Pharmacovigilance System Master File

Las Buenas Prácticas de Farmacovigilancia (Good Pharmacovigillance Practices – GVP) publicadas por la EMA constituyen la...

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EMA proposed changes to preparation of risk management plans....

In early 2016, the European Medicines Agency (EMA) started a major revision process of the good pharmacovigilance practice...

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Keys for adapting to the new Pharmacovigilance Environment

At the end of 2017, a new version of Eudravigilance went online to manage suspected adverse reactions to medicines. This...

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RMP changes to GVP Module V- A doorway to better risk-oriented,...

On 31 March 2017, the EMA released a second revision of Module V- Risk Management Systems of Good Pharmacovigilance Practice...

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Addendum to the clinical overview

The addendum to the clinical overview collects all cumulated effectiveness and safety data related to a medicinal product...

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