PVpharm at Upcoming EVWeb Training – This December!

PVpharm at Upcoming EVWeb Training – This December!

  • Post published:November 28, 2024

José Ortiz, CEO of PVpharm, will be participating as a trainer in the upcoming EVWeb training, scheduled from Monday, 02 December to Friday, 06 December 2024. This comprehensive online training will take place all day and is tailored for professionals involved in reporting and analyzing suspected adverse reactions. About the Training EudraVigilance is the EU's system for managing and analyzing information on adverse reactions to medicines authorized or studied within the European Economic Area (EEA). This training focuses on the mandatory use of the ISO Individual Case Safety Report (ICSR) standard, based on ICH E2B(R3) modalities, which became effective on…

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

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 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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PHARMACOVIGILANCE TRAINING III Edition – Madrid 21-22 May 2020, Save the date! – UPDATE: postponed

PHARMACOVIGILANCE TRAINING III Edition – Madrid 21-22 May 2020, Save the date! – UPDATE: postponed

  • Post published:March 20, 2020

PVpharm is organizing the III Edition of the PHARMACOVIGILANCE TRAINING, this year it will be held in Madrid. The training was originally scheduled for the 21-22 of May 2020, but it has been posponed due to COVID-19. We will publish the new dates very soon. The previous editions in 2018 and 2019 were really successful, so we continue with a similar format, giving the participants now the chance to send questions to the speakers in advance. This year again, we have the honour to count with very relevant and experienced Speakers that will share their PV knowledge with the participants: Doris…

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ISO/ICH E2B(R3) Individual Case Safety Reporting in the EU: Hands-on Training Course using the EudraVigilance System Madrid (25th-27th March)

ISO/ICH E2B(R3) Individual Case Safety Reporting in the EU: Hands-on Training Course using the EudraVigilance System Madrid (25th-27th March)

  • Post published:January 31, 2020

PVpharm is pleased to inform that our CEO, Jose Alberto Ayala Ortiz, will be participating as an instructor in a hands-on training course on the ISO/ICH E2B(R3) Individual Case Safety Reporting in the EU. The course will take place in Madrid from 25th to 27th of March and will provide the extensive information regarding EMA required knowledge evaluation, on how to report, view and download ICSRs using the EudraVigilance system and principles of EVDAS. This hands-on training course covers: In depth explanation and practical examples for creating, sending and accessing ICSRs in the ISO/ICH E2B(R3) format based on the EU ICSR…

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