Online XEVMPD training 21-23 February 2024

  • Post published:January 22, 2024

JosĂ© Alberto Ayala Ortiz, CEO of PVpharm, will be participating as trainer in the next XEVMPD training on 21-23 February 2024. The training will be delivered online in the morning time (09:00-13:00 CET). 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…

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Online XEVMPD training 27-29 November 2023

  • Post published:November 24, 2023

JosĂ© Alberto Ayala Ortiz, CEO of PVpharm, will be participating as trainer in the next XEVMPD training on 21-23 February 2024. The training will be delivered online in the morning time (09:00-13:00 CET). 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…

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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.

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PVpharm initiates a collaboration with the Leiden University Medical Center (LUMC) in the Netherlands

  • Post published:May 3, 2023

We are happy to announce that PVpharm have enter in a new agreement with Leiden University Medical Center (LUMC) to provide safety and regulatory consulting. LUMC was formed from a collaboration between the Academic Hospital Leiden and the Faculty of Medicine of Leiden University, and provides scientific and material support to first steps of the drug development in humans. As an innovator, the LUMC stands for improving healthcare and people's health. This is done on the basis of leading research and innovative education. The objective of the LUMC is to be one of the top 10 University Medical Centers in…

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Online XEVMPD training 10-12 May 2023

  • Post published:April 27, 2023

JosĂ© 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…

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Online XEVMPD training 13-15 September 2021

  • Post published:September 3, 2021

JosĂ© 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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