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!

IV PV TRAINING: unique pharmacovigilance training experience

Post published:July 11, 2023

PVpharm led the way in pharmacovigilance training by innovatively organizing another edition of its Pharmacovigilance Training. This 3rd edition was hosted on May, 2022.

Faculty at Signal Management training by DIA June 2023

Post published:June 16, 2023

On 12-15 June 2023, 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…

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/

PVpharm starts a new collaboration with the International AIDS Vaccine Initiative (IAVI)

Post published:May 22, 2023

We are so excited to announce the new collaboration agreement signed by our company with the International AIDS Vaccine Initiative (IAVI) to provide pharmacovigilance and regulatory consulting. IAVI is a nonprofit scientific research organization that develops vaccines and antibodies for HIV, tuberculosis, emerging infectious diseases (including COVID-19), and other neglected diseases, with a clear commitment to develop affordable and accesible solutions to these diseases. In the same way as our collaboration with the Leiden University Medical Center (LUMC) or with the Center for Human Drug Research (CHDR), PVpharm works to provide pharmacovigilance support in pre-approval phases of the development of innovative drugs. In this agreement, we…

Clinical Trials Information System (CTIS) training 2-5 May 2023

Post published:April 27, 2023

The European Commission has informed that the entry into application of the Clinical Trials Regulation (CTR)