IV PV TRAINING: unique pharmacovigilance training experience
PVpharm led the way in pharmacovigilance training by innovatively organizing another edition of its Pharmacovigilance Training. This 3rd edition was hosted on May, 2022.
PVpharm led the way in pharmacovigilance training by innovatively organizing another edition of its Pharmacovigilance Training. This 3rd edition was hosted on May, 2022.
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…
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/
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…
Isabella Pallagiano from PVpharm will be participating as a trainer, together with Calin Lungu and Vojtech Kvita in the next EVWeb training on 22-26 May 2023. The training will be delivered online in the morning time (9:00-13:30 CEST). 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…
PVpharm is in "El Economista" on 9th May 2023, the news diary published an article about PVpharm; where our CEO, José Alberto Ayala Ortiz, introduces our company, explains what pharmacovigilance is and how does PVpharm deal with different regulations. PVpharm is a global reference in Pharmacovigilance: https://www.eleconomista.es/branded-content/noticias/12258631/05/23/jose-alberto-ayala-ortiz-pvpharm-somos-una-referencia-global-en-el-campo-de-la-farmacovigilancia.html You can follow us on LinkedIn and learn more about us clicking here.
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…
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…
This training will focus on explaining 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).
The European Commission has informed that the entry into application of the Clinical Trials Regulation (CTR)