Pharmacovigilance services for the Pharmaceutical Industry.

Online XEVMPD training 13-15 September 2021

  • 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…

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Risk Management Plan (EU-RMP) Creation Virtual Live Training Course

  • August 24, 2021

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…

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Online XEVMPD training 14-16 June 2021

  • May 19, 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…

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Vojtech Kvita from PVpharm to train EudraVigilance Data Analysis System (EVDAS): Practical approach on use for signal management in the EU

  • April 29, 2021

PVpharm is pleased to inform that Vojtech Kvita, will train the EudraVigilance Data Analysis System (EVDAS): Practical approach on use for signal management in the EU in the following dates: 24 Jun 2021 9:00 AM – 25 Jun 2021 1:00 PM 08 Jul 2021 9:00 AM – 09 Jul 2021 1:00 PM The online course will provide the extensive information regarding concepts, access policy, and use of the EudraVigilance Data Analysis System (EVDAS) for signal detection. Experienced trainers using EVDAS on a regular basis will share practical advice on how to download and interpret the data and use it for signal detection from a marketing authorisation holder perspective.…

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Online XEVMPD training 19-21 April 2021

  • April 7, 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…

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PVpharm opens an office in Prague

  • March 11, 2021

We are happy to announce that PVpharm is opening an office in Prague (Czech Republic). For all our partners and collaborators we are welcoming you at our new location! PVpharm S.L. - Prague, Smichoff, Plzeňská 3350/18, 150 00 Praha 5-Smíchov, Chequia

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Jan Kolouch from PVpharm to speak at conforum – pharmacovigilance seminar January 21, 2021

  • January 18, 2021

We are happy to inform that Jan Kolouch, Head of Pharmacovigilance and Clinical Safety at PVpharm, will be speaking at the pharmacovigilance seminar on January 21st , 2021. This seminar will be in Czech and organized virtually. Jan will be speaking together with other speakers, including representatives from national agency (SUKL). You can see the full information of this event at the link below: https://www.konferenceseminare.cz/farmakovigilance-aktualne-a-prehledne This online seminar will be conducted in the local language focusing on periodic safety reports and their evaluation, pharmacovigilance inspections and findings, pharmacovigilance reporting, signal management, EudraVigilance and Brexit. PVpharm also provides in-house trainings for pharmaceutical…

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Jan Kolouch from PVpharm participates as co-trainer in the Eudravigilance EVWeb training 7-11 December 2020

  • December 4, 2020

PVpharm is pleased to inform that Jan Kolouch, will be participating as an co-trainer in the Eudravigilance EVWeb training, 7-11 December 2020, 14:00 – 18:30 The online course 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 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 Implementation GuideThe use of the EudraVigilance web application (EVWEB) functionalities to describe the use of the E2B(R3) format and to practice examples for…

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Entrevista a José Alberto Ayala Ortiz – Visitadores Médicos Digitales (Spanish Video)

  • November 26, 2020

https://www.youtube.com/watch?v=fdfovftF_Zg&feature=youtu.be Today we share this interview in Spanish, where José Alberto Ayala Ortiz is invited in an interview on "Visitadores Médicos Digitales" by Miguel Ángel Martínez Barreira. Please watch the video here. PVpharm is also organizing in-house trainings in pharmacovigilance for pharmaceutical companies and CROs, please contact us for further information.

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Online XEVMPD training 23-25 November 2020

  • November 11, 2020

José Ortiz will be participating as a trainer together with Raj K. Bains and Calin Lungu in the next XEVMPD training on 23-25 November 2020. 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…

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