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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Pharmacovigilance
Pharmacovigilance
November 27, 2019
Development Safety Update Report (DSUR)
In September 2010, the International Conference Harmonisation developed the ICH E2F Guideline for the Development Safety...
Pharmacovigilance
November 27, 2019
Periodic Benefit-Risk Evaluation Report (PBRER)
According to European Medicaments Agency (EMA) guidelines, already implemented since 2012; Marketing Authorization Holders...
Pharmacovigilance
November 26, 2019
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....
Pharmacovigilance
November 21, 2019
Pilot extension in EVDAS
The European pharmacovigilance legislation requires marketing authorization holders (hereinafter MAHs) to continuously monitor...
Pharmacovigilance
November 21, 2019
GVP Módulo II: Pharmacovigilance System Master File
Las Buenas Prácticas de Farmacovigilancia (Good Pharmacovigillance Practices – GVP) publicadas por la EMA constituyen la...
Pharmacovigilance
November 21, 2019
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...
Pharmacovigilance
November 21, 2019
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...
Pharmacovigilance
November 20, 2019
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...
Pharmacovigilance
November 11, 2019
Addendum to the clinical overview
The addendum to the clinical overview collects all cumulated effectiveness and safety data related to a medicinal product...
