Faculty at Signal Management training by DIA June 2023

  • Post published:June 16, 2023

On 12-15 June 2023, JosĂ© 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…

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José Alberto Ayala Ortiz to participate in the AEFI Symposium 2023

  • Post published:June 1, 2023

We are happy to announce that José Alberto Ayala Ortiz, PVpharm's CEO will be participating in one session of the 2023 Pharmacovigilance symposium organized by AEFI. During the session, José will be talking about safety in food or food supplements. Please take a look to the program at this link: https://www.aefi2023.com/

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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…

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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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DIA Pharmacovigilance System Master File (PSMF) and Global PSMF virtual courses (18-20 April 2023)

  • Post published:April 12, 2023

JosĂ© Ortiz will be participating as a trainer together with Marcela Fialova in the Pharmacovigilance System Master File (PSMF) and Global PSMF courses organized by DIA. The training will be delivered online from 9:00 AM to 1:00 PM (CEST) on April 18 to 20, 2023. These virtual live training courses covers essential concepts and guidance about the Pharmacovigilance System Master File (PSMF) and the PSMF from a global context. This key document describes the company’s pharmacovigilance system, supporting, and documenting its compliance with the requirements laid down in the EU legislation and is the first document requested by a Competent…

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Faculty at Signal Management training by DIA November 2022

  • Post published:November 24, 2022

On 21-24 November 2022, JosĂ© 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…

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DIA QPPV forum 2022 – No slides presentation
QPPV Forum 2022

DIA QPPV forum 2022 – No slides presentation

  • Post published:November 7, 2022

JosĂ© Ortiz, PVpharm CEO, participated one more time as a speaker in the QPPV forum 2022 organized by DIA. https://www.diaglobal.org/en/conference-listing/meetings/2022/11/global-forum-for-qualified-persons-for-pharmacovigilance-qppv JosĂ© presented in the Session 2: Pharmacovigilance System Oversight on 09 Nov 2022 9:00 AM – 09 Nov 2022 10:30 AM together with other key speakers as: -Sina Schader, DrMed EU and UK QPPV Abbvie, Germany -Gabrielle Amselem Deputy EU/UK QPPV Alexion, France -Hayley Fletcher Principal Quality Lead, PDQ Quality Assurance Process GVP Roche Products Ltd., United Kingdom Session chairs were: -Gemma Jimenez Sese Patient Safety Director, EU QPPV Almirall, S.A., Spain -Kiernan Trevett, MSc Principal Quality Lead, PDQ Quality…

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DIA Pharmacovigilance System Master File (PSMF) virtual course (2-3 November 2022)

  • Post published:October 25, 2022

JosĂ© Ortiz will be participating as a trainer together with Marcela Fialova and Claire Longman, MSc Interim Head of GCP and Senior Pharmacovigilance Inspector at the Medicines and Healthcare products Regulatory Agency (MHRA), United Kingdom in the Pharmacovigilance System Master File (PSMF) course organized by DIA. The training will be delivered online from 1:00 PM to 5:00 PM (CEST) on November 2 to 3, 2022. This virtual live training course covers essential concepts and guidance about the Pharmacovigilance System Master File (PSMF). This key document describes the company’s pharmacovigilance system, supporting, and documenting its compliance with the requirements laid down…

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