New Clinical Trials Information System (CTIS): key areas
The European Commission has informed that the entry into application of the Clinical Trials Regulation (CTR) and hence the go-live date for the CTIS will be on 31 January 2022.
PVpharm’s offsite meeting 2021: a memorable event (VIDEO)
PVpharm has enjoyed several sessions where the team has enjoyed sailing on one of the most wonderful landscapes of Spain, the coast of Almeria.
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).
PVpharm contributes to a recent article about the Covid vaccine
"Pharmacovigilance in times of COVID-19 vaccines", is an article published in the Spanish journal Pharmatech and in which José Alberto Ayala Ortiz has been co-author. The world is facing the unprecedented challenge of the SARS-CoV-2 pandemic. The hope for a normal life relied on vaccines is compromised by messages that question them. For this reason, pharmacovigilance activities carried out by authorities, pharmaceutical laboratories, health professionals and patients are essential to assess information and not to rely on "fake news". In this regard, the article aims to highlight the role of pharmacovigilance. It is important that society, in addition to being…
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…
José Ortiz to participate in the AEFI Symposium 2021
We are happy to announce that José Ortiz, PVpharm's CEO will be participating in one session of the 2021 Pharmacovigilance symposium organized by AEFI. During the session, José will be talking about outsourcing of pharmacovigilance activities. Please take a look to the program at this link: https://www.aefi2021.com/
Online XEVMPD training 19-21 April 2021
José Ortiz will be participating as a trainer together with Dr. Calin Lungu in the next XEVMPD training on 19-21 April 2021. The training will be delivered online. 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 in…