DIA Pharmacovigilance System Master File (PSMF) and Global PSMF virtual courses (30 October and 2-3 November 2023)

Post published:October 30, 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 13:00 PM to 17:00 PM (CET) on October 30 and November 2 to 3, 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…

Pharmacovigilance Webinar – Audit and Inspection (8 September 2023)

Post published:September 8, 2023

José Ortiz will be participating as a trainer together with other speakers in the Pharmacovigilance Webinar - Audit and Inspection organized by the Global PV Society. The training will be delivered online from 11:00 AM to 13:30 PM (CEST) on September 8, 2023. Interested in joining? https://lnkd.in/dt-J53Bf **PVpharm is also organizing in-house training in pharmacovigilance for pharmaceutical companies and CROs, please contact us for further information.**

DIA Pharmacovigilance QMS virtual course (18-21 September 2023)

Post published:August 28, 2023

José Ortiz will be participating as a trainer together with Wendy Huisman in the Pharmacovigilance Quality Management System course organized by DIA. The training will be delivered online from 13:00 AM to 17:30 PM (CEST) on September 18 to 21, 2023. The course will employ a mix of informative sessions, real case studies, and hands-on interactive exercises where attendees will be able to apply what they have learned. Learners will leave the course with an understanding of how elements of the Pharmacovigilance and Quality Management Systems fit together to achieve regulatory compliance. Course Highlights Quality and the Quality System QMS…

José Alberto Ayala Ortiz selected as one of the top ten CEOs of 2023

Post published:August 22, 2023

We are very glad to announce that José Alberto Ayala Ortiz has been selected as one of the top ten CEOs of 2023. Industry Tech Outlook has chosen José, a full article has been issued at the magazine website, it can be found here: https://industry-techoutlook.com/magazine/Top-10-CEOs-Of-2023/ Being the CEO of PVpharm, José is a visionary and inspirational leader. He sets a clear direction for the organization's future while motivating and uniting the organization. José’s leadership drives growth, innovation, and success, creating a positive work environment, attracting top talent, and building solid stakeholder relationships. The company has been growing in business since…

Meet us in September! at Farmaforum (Madrid) and BIOSPAIN (Barcelona)

Post published:August 18, 2023

PVpharm is going to participate in the next events of the pharmaceutical and biotechnology industry in Spain. Farmaforum will be held in Madrid from September 19 to 20, and BIOSPAIN will be held in Barcelona from September 26 to 28. Come visit us and let's talk about pharmacovigilance services, safety in clinical trials, audits, quality and many other topics related to drug development. We are looking forward to seeing you!

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/

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…

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…