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José Ortiz to participate as a speaker in the DIA QPPV forum 2022
Jose Ortiz will be presenting on the QPPV forum 2022 organized by DIA

José Ortiz to participate as a speaker in the DIA QPPV forum 2022

  • September 17, 2022

José Ortiz, PVpharm CEO will participate one more time as a speaker in the next QPPV forum organized by DIA. You can find more information in the link: https://www.diaglobal.org/en/conference-listing/meetings/2022/11/global-forum-for-qualified-persons-for-pharmacovigilance-qppv José will be presenting in the Session 2: Pharmacovigilance System Oversight on 09 Nov 2022 9:00 AM – 09 Nov 2022 10:30 AM https://www.diaglobal.org/en/conference-listing/meetings/2022/11/global-forum-for-qualified-persons-for-pharmacovigilance-qppv/agenda/09/session-2-pharmacovigilance-system-oversight?ref=Session2PharmacovigilanceSystemOversight About the QPPV forum: In a changing and expanding world, this is still the only forum designed for QPPVs by QPPVs, now celebrating its 16th year and still going strong. Back in a face-to-face format, it brings together QPPVs from all over the world to discuss how…

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

  • 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…

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CTIS for sponsors of clinical trials

  • 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.

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New training Online XEVMPD for SPONSORS 17 Feb 2022

  • 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).

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Online XEVMPD training 14-16 Feb 2022

  • 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.

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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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