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…

Feria de Empleo UAL 2023

PVpharm participates in “Feria de Empleo 2023” at the University of Almería

Post published:April 11, 2023

PVpharm will be participating in the “Feria de Empleo 2023”, along with other companies and organizations from Almería like Cosentino, Cajamar, Kimitec, FAAM or Verdiblanca. This job fair dedicates two days in which local companies have the opportunity to make themselves known in a closer way and thus create a common space where both, the student and the company, can mutually exchange and enrich each other. -When? Monday, 17th April: 10:30 am – 2 pm 4 pm – 7 pm Tuesday, 18th April: 10 am – 14 pm -Where? The main avenue of the University of Almeria

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…

Online XEVMPD training 13-15 and Sponsors XEVMPD 16-17 Feb 2023

Post published:January 16, 2023

José Ortiz will be participating as a trainer in the next XEVMPD training on 14-16 Feb 2022. The training will focus on explaining the guidance and specifically the mandatory data elements necessary for the electronic submission of information on medicinal products.

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…

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.

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…

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

Post published:October 25, 2022

José 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…

PVpharm at Farmaforum 2022 (Video)

Post published:October 18, 2022

PVpharm participated in the 2022 edition of FARMAFORUM. PVpharm presented their services. We created a VIDEO that you can see below. Pharmacovigilance and quality services GVP, GCP, GDP and GMP: As a Pharmacovigilance service provider, PVpharm offers a full range of PV services for the pharmaceutical industry, sponsors of clinical trials and other service provider companies. PVpharm also provides a risk-based Pharmacovigilance Audit Service, which focuses on the areas of highest risk to an organisation’s pharmacovigilance system, taking into account applicable local regulatory requirements. Our approach is risk and process based, our objective is to improve your pharmacovigilance system in order to…

PVpharm participates in the 2022 European Researchers’ Night

Post published:September 29, 2022

The European Researchers' Night is a Europe-wide public event, which displays the diversity of science and its impact on citizens' daily lives in fun, inspiring ways. This year, the event will take place in 25 countries on Friday 30 September 2022. The European Researchers' Night aims to: -bring research and researchers closer to the public-promote excellent research projects across Europe and beyond-increase the interest of young people in science and research careers-showcase the impact of researchers’ work on people’s daily lives The European Researchers’ Night attracts each year more than 1 million visitors in Europe and beyond. Juego de la…