Pharmacovigilance services for the Pharmaceutical Industry.

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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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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CTIS Reminder for Sponsors: Register your organization and Administrator!
CTIS Highlights

CTIS Reminder for Sponsors: Register your organization and Administrator!

  • December 19, 2021

The go-live of CTIS on 31 January 2022 is now less than two months away, and organisations throughout Europe and beyond are undergoing preparations for CTIS. Users are reminded that certain preparatory steps must be taken before it is possible to use CTIS. Sponsor organisations opting for the organisation-centric approach that are not yet registered in EMA’s Organisation Management System (OMS) must do so before using CTIS. Registration in OMS can be done by visiting the OMS webpage of the Substances, Products, Organisations and Referentials (SPOR) portal. An EMA account with a SPOR user role is required in order to…

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