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

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

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…

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

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

  • Post published:April 12, 2023

José 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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PVpharm to provide pharmacovigilance and CTIS support to the Centre for Human Drug Research of the Netherlands (CHDR).

PVpharm to provide pharmacovigilance and CTIS support to the Centre for Human Drug Research of the Netherlands (CHDR).

  • Post published:January 24, 2023

We are happy to announce that PVpharm have enter in a new agreement with Centre for Human Drug Research (CHDR) to provide safety and regulatory consulting. This prestigious foundation, based in Leiden (NL) and with three decades of history, provide scientific and material support to first steps of the drug development in humans (phase I and II of Clinical trials). Our collaboration will focus on helping about EMA’s Clinical Trial Information System (CTIS) and pharmacovigilance tasks, essential in these steps of drug development. With different therapeutic areas of research, CHDR is a leading organization in this field, with projects as…

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Faculty at Signal Management training by DIA November 2022

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…

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Round table and discussion – Differences between Phase III and Phase IV Drug Safety and Pharmacovigilance – University of Valladolid

Round table and discussion – Differences between Phase III and Phase IV Drug Safety and Pharmacovigilance – University of Valladolid

  • Post published:November 12, 2022

José Alberto Ayala Ortiz, PVpharm CEO, will participate together with Andrea Álvarez, QPPV of FAES FARMA in a Round table and discussion about "Differences between Phase III and Phase IV Drug Safety and Pharmacovigilance" organized by the University of Valladolid. The conference will be held on 17th November 2022 at 18:00 CET, and it is free of access!! Please join here. https://forms.gle/FEDtVzLfZJfBxq448?fbclid=IwAR1eQx0ISwSau6DZmHZ-ZszE4-QJPcMpfm9wuXa2pMCinMTg0U8LGmTnQNo PVpharm is also organizing in-house trainings in pharmacovigilance for pharmaceutical companies and CROs, please contact us for further information.

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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

José 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 José 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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