Pilot extension in EVDAS

The European pharmacovigilance legislation requires marketing authorization holders (hereinafter MAHs) to continuously monitor the data published in Eudravigilance and to inform the Agency and National Competent Authorities (NCA) of validated signals detected in the database.   On November 22, 2017, it allows to access to the database  (EVDAS) includes in EudraVigilance that allows MAH to…

RMP changes to GVP Module V- A doorway to better risk-oriented, scientifically valuable RMPs

On 31 March 2017, the EMA released a second revision of Module V- Risk Management Systems of Good Pharmacovigilance Practice (GVP) (EMA/838713/2011 Rev 2), together with a revised Guidance on the format of the risk management plan (RMP) in the EU – in integrated format (EMA/PRAC/613102/2015 Rev 2). During the transition period, RMPs prepared according…

Pharmacovigilance: 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 (GVP) Module V on risk management systems. Consequent to this, the Agency shared its intention to implement new modifications in the preparation of risk management plans (RMPs), in order to express the experience gained in the last few years. A public consultation was deemed…

Periodic Benefit-Risk Evaluation Report (PBRER)

According to European Medicaments Agency (EMA) guidelines, already implemented since 2012; Marketing Authorization Holders (MAHs) have to submit periodic updated safety reports following GVP Module VII. The objective of this submission is to harmonise all the existing information relating to every single medicinal product; in order to update their risk-benefit profile. This strategy allows EMA…

Farmacovigilancia: una disciplina esencial en la seguridad del medicamento

La Farmacovigilancia (FV) agrupa las actividades relativas a la identificación, cuantificación, evaluación,  y prevención de los efectos adversos de los medicamentos o cualquier otro problema relacionado con la seguridad de los mismos. Se basa en procedimientos que fijan las líneas de actuación ante una sospecha de reacción adversa (cómo notificarla, quién debe hacerlo y a…