DIA Pharmacovigilance QMS virtual course (27 February-1 March 2024)

Post published:January 27, 2024

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 9:00 AM to 13:30 PM (CET) between the 27th of February and the 1st March, 2024. 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…

Code of ethics in the use of Artificial Intelligence

Post published:January 27, 2024

At PVpharm, we aim to work with pharmaceutical, biotech, and MedTech companies, providing new ideas and making solutions that make health better for everyone. We believe that Artificial Intelligence (AI) can really change the way we do pharmacovigilance, improving our work every day. The large revolution in the implementation of tools that use AI in the day-to-day work of pharmacovigilance is undeniable, but we must keep a critical and analytical eye. That is why at PVpharm we have created a code of ethics for the use of AI to establish guidelines to be followed to ensure a safe, legal, and…

Online EVWeb training 29 January-2 February 2024

Post published:January 26, 2024

José Ortiz, CEO of PVpharm will be participating as a trainer, in the next EVWeb training on 29 Janyary 2 February 2024. The training will be delivered online in the morning time (9:00-13:30 CET). 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 Trials-National Competent Authorities or…

Online XEVMPD training 21-23 February 2024

Post published:January 22, 2024

José Alberto Ayala Ortiz, CEO of PVpharm, will be participating as trainer in the next XEVMPD training on 21-23 February 2024. The training will be delivered online in the morning time (09:00-13:00 CET). 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 of medicinal products. Please…