Development substance data request from EMA – Action required by 01-09-2023

Post published:July 14, 2023

As an owner of development substance data in the Extended EudraVigilance Medicinal Product Dictionary (xEVMPD), the EMA is requesting an action by 1st of September 2023. For the unmapped substance data, the EMA is asking organizations to raise a request for the creation of new approved substance data. This activity requires time, expertise and experience with the xEVMPD. In PVpharm we are experts in xEVMPD, as well as xEVMPD trainers. We can help you to perform this activity on time. Please contact us.

Faculty at Signal Management training by DIA June 2023

Post published:June 16, 2023

On 12-15 June 2023, José Ortiz provided the training faculty for the Signal Management training organized by DIA. This training provides knowledge over Signal Management to the participants, so they can apply the basic concepts and principles of signal detection in pharmacovigilance, from simple visualisation and tabulation methods to sophisticated data mining techniques. • Design the signal management process for institutions and companies of various sizes, portfolios and geographical presence, based on the possibilities and limitations of their data and resources • Understand key messages from the current European and US regulations on signal management, to best manage implications also…

Online EVWeb training 22-26 May 2023

Post published:May 17, 2023

Isabella Pallagiano from PVpharm will be participating as a trainer, together with Calin Lungu and Vojtech Kvita in the next EVWeb training on 22-26 May 2023. The training will be delivered online in the morning time (9:00-13:30 CEST). The training is targeted to: -Users who have to report and analyse suspected adverse reactions in the pre- and post-authorisation phase using the ISO/ICH E2B(R3) ICSR format-Users of EudraVigilance – new users and users already trained on working with EudraVigilance-Professionals performing electronic transmission of ICSRs, who operate as Gateway traders or as WebTrader (i.e., who use EVWEB or EV Post)-Sponsors of Clinical…

Online XEVMPD training 10-12 May 2023

Post published:April 27, 2023

José Alberto Ayala Ortiz, Isabella Pallagiano and Monika Gappa from PVpharm will be participating as trainers in the next XEVMPD training on 10-12 May 2023. 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…

Training Online XEVMPD for SPONSORS 4-5 May 2023

Post published:April 27, 2023

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 13-15 and Sponsors XEVMPD 16-17 Feb 2023

Post published:January 16, 2023

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.

Faculty at Signal Management training by DIA November 2022

Post published:November 24, 2022

On 21-24 November 2022, José Ortiz provided the training faculty for the Signal Management training organized by DIA. This training provides knowledge over Signal Management to the participants, so they can apply the basic concepts and principles of signal detection in pharmacovigilance, from simple visualisation and tabulation methods to sophisticated data mining techniques. • Design the signal management process for institutions and companies of various sizes, portfolios and geographical presence, based on the possibilities and limitations of their data and resources • Understand key messages from the current European and US regulations on signal management, to best manage implications also…

New training Online XEVMPD for SPONSORS 17 Feb 2022

Post published: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).

Online XEVMPD training 14-16 Feb 2022

Post published: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.

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…