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

CTIS Reminder for Sponsors: Register your organization and Administrator!

  • Post published: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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PVpharm on the EMA course: Mandatory use of ISO/ICH E2B(R3) Individual Case Safety Reporting in the EU

PVpharm on the EMA course: Mandatory use of ISO/ICH E2B(R3) Individual Case Safety Reporting in the EU

  • Post published:September 28, 2021

PVpharm is pleased to inform that José Ortíz, will be a trainer in the course "Mandatory use of ISO/ICH E2B(R3) Individual Case Safety Reporting in the EU: Practical training course with the EudraVigilance system" carried out by the European Medicines Agency (EMA).

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DIA Pharmacovigilance QMS virtual course (21-24 September)

DIA Pharmacovigilance QMS virtual course (21-24 September)

  • Post published: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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Online XEVMPD training 13-15 September 2021

Online XEVMPD training 13-15 September 2021

  • Post published:September 3, 2021

José Ortiz will be participating as a trainer in the next XEVMPD training on 13-15 September 2021. The training will be delivered online in the morning time (9:00-13:00 CEST). The training focuses on explaining the guidance and specifically 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). It includes exercises in the XEVPRM data entry tool (EVWEB) for the electronic submission and maintenance of different types of medicinal products. Please read more and register…

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Risk Management Plan (EU-RMP) Creation Virtual Live Training Course

Risk Management Plan (EU-RMP) Creation Virtual Live Training Course

  • Post published:August 24, 2021

Jan Kolouch will be participating as a trainer in the next Risk Management Plan training on 14-16 September 2021 organized by DIA. The training will be delivered online in the morning time (09:00-13:00 CEST). This virtual live course is aimed at the practical aspects of the EU Risk Management Plan (EU-RMP) creation process. We will demonstrate the various uses of the EU-RMP within the lifecycle of medicinal products, medical writing process and RMP management process. It will provide a detailed understanding of the GVP Module V (Rev. 2) with all potential implications for the marketing authorisation holders. The participants will…

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Online XEVMPD training 14-16 June 2021

Online XEVMPD training 14-16 June 2021

  • Post published:May 19, 2021

José Ortiz will be participating as a trainer in the next XEVMPD training on 14-16 June 2021. The training will be delivered online in the afternoon time (14:00-18:00 CEST). The training focuses on explaining the guidance and specifically 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). It includes exercises in the XEVPRM data entry tool (EVWEB) for the electronic submission and maintenance of different types of medicinal products. Please read more and register…

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