Pharmacovigilance services for the Pharmaceutical Industry.

Is the Local Medical Literature Search in Pharmacovigilance really an obligation?

  • January 19, 2022

It is well known that the medical literature is a significant source of information for the monitoring of the safety profile and of the risk-benefit balance of medicinal products. However, we may have doubts about whether it is really mandatory or not. And indeed, yes, it is an obligation. The European Medicines Agency confirms this in the Good Pharmacovigilance Practices (GVP) Module VI: "The marketing authorisation holder should ensure that the literature review includes the use of reference databases that contain the largest reference of articles in relation to the medicinal product properties." "In addition, marketing authorisation holders should have procedures…

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DIA Pharmacovigilance QMS virtual course (25-28 January)

  • January 19, 2022

José Ortiz will be participating as a trainer together with Wendy Huisman in the Pharmacovigilance Quality Management System course organized by DIA. The training will be delivered online from 9:00 AM to 01:30 PM (CEST) on January 25 to 28, 2022. The course will employ a mix of informative sessions, real case studies, and hands-on interactive exercises where attendees will be able to apply what they have learned. Learners will leave the course with an understanding of how elements of the Pharmacovigilance and Quality Management Systems fit together to achieve regulatory compliance. Course Highlights Quality and the Quality SystemQMS OverviewPV…

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PVpharm contributes to a recent article about the Covid vaccine

  • September 23, 2021

"Pharmacovigilance in times of COVID-19 vaccines", is an article published in the Spanish journal Pharmatech and in which José Alberto Ayala Ortiz has been co-author. The world is facing the unprecedented challenge of the SARS-CoV-2 pandemic. The hope for a normal life relied on vaccines is compromised by messages that question them. For this reason, pharmacovigilance activities carried out by authorities, pharmaceutical laboratories, health professionals and patients are essential to assess information and not to rely on "fake news". In this regard, the article aims to highlight the role of pharmacovigilance. It is important that society, in addition to being…

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DIA Pharmacovigilance QMS virtual course (21-24 September)

  • September 14, 2021

José Ortiz will be participating as a trainer together with Wendy Huisman in the Pharmacovigilance Quality Management System course organized by DIA. The training will be delivered online from 1:30 PM to 6:00 PM (CEST). The course will employ a mix of informative sessions, real case studies, and hands-on interactive exercises where attendees will be able to apply what they have learned. Learners will leave the course with an understanding of how elements of the Pharmacovigilance and Quality Management Systems fit together to achieve regulatory compliance. Course Highlights Quality and the Quality SystemQMS OverviewPV SystemSystem, Processes, Quality DocumentsPSMF and PV…

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