Time to meet in person again: PV TRAINING III EDITION
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.
New training Online XEVMPD for SPONSORS 17 Feb 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
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.
DIA Pharmacovigilance QMS virtual course (25-28 January)
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…
PVpharm participates in the 8th Annual Pharmacovigilance Symposium
PVpharm is pleased to inform that José Ortiz, will be a speaker in the online 8th Annual Pharmacovigilance Symposium webinar with the theme “Redefining Pharmacovigilance Frontiers for Augmenting Healthcare”, carried out by Pharmacovigilance Council of the Indian Society for Clinical Research (ISCR).
PVpharm on the EMA course: Mandatory use of ISO/ICH E2B(R3) Individual Case Safety Reporting in the EU
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).
DIA Pharmacovigilance QMS virtual course (21-24 September)
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…
Online XEVMPD training 13-15 September 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…
Risk Management Plan (EU-RMP) Creation Virtual Live Training Course
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…
Online XEVMPD training 14-16 June 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…