DIA Pharmacovigilance QMS virtual course (19-22 September 2022)

Post published:September 13, 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 September 19 to 22, 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…

CTIS for sponsors of clinical trials

Post published:July 28, 2022

Sponsors of clinical trials in the EU should be aware that the EMA’s Management Board, on 31 January 2022 established a harmonized approach to submission, assessment, and authorization of clinical trial applications.

PVpharm to present a key trending subject at Farmaforum 2022

Post published:June 23, 2022

In the next edition (October 2022), PVpharm will not only participate as an exhibitor but also as a speaker, leading one of the conferences of this benchmark event.

III PV TRAINING: Leading experts make success possible

Post published:June 22, 2022

PVpharm led the way in pharmacovigilance training by innovatively organizing another edition of its Pharmacovigilance Training. This 3rd edition was hosted on May, 2022.

Time to meet in person again: PV TRAINING III EDITION

Post published:March 24, 2022

PVpharm organizes its successful Pharmacovigilance Training. This 3rd edition will be hosted in Madrid on May 30 and 31, 2022, with the option of attending online.

The University of Valladolid counts on PVpharm as experts for its PV course

Post published:March 3, 2022

The FUNGE will organize the XXVI Edition of the well-known "Pharmacovigilance for Healthcare Professionals" course. On this occasion, Jose Alberto Ayala Ortiz, CEO of PVpharm, will participate as a trainer.

New training Online XEVMPD for SPONSORS 17 Feb 2022

Post published:February 11, 2022

This training will focus on explaining the mandatory data elements necessary for the electronic submission of information on medicinal products, applying the format of the eXtended EudraVigilance Product Report Message (XEVPRM) and the use of the XEVMPD data entry tool (EVWEB).

Online XEVMPD training 14-16 Feb 2022

Post published:February 11, 2022

José Ortiz will be participating as a trainer in the next XEVMPD training on 14-16 Feb 2022. The training will focus on explaining the guidance and specifically the mandatory data elements necessary for the electronic submission of information on medicinal products.

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

Post published: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…

DIA Pharmacovigilance QMS virtual course (25-28 January)

Post published: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…