José Ortiz will be one of the speakers at the International Pharmaceutical Industry Congress - Latin America 2021. This is the most important event of the Pharmaceutical Industry in the region.
José Ortiz will be participating as a trainer together with Marcela Fialova and Silvia Danesi in the Pharmacovigilance System Master File (PSMF) and Global PSMF courses organized by DIA. The training will be delivered online from 13:00 to 17:00 (CET) on November 27-28 and 29, 2024. 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…
On 18-21 November 2024, 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 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 to 17:30 (CEST) between the 16th and the 19th of September, 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 the Quality System…
José Ortiz will be one of the speakers at the International Pharmaceutical Industry Congress - Latin America 2021. This is the most important event of the Pharmaceutical Industry in the region.
José Ortiz will be participating as a trainer together with Marcela Fialova and Zoe Hamill in the Pharmacovigilance System Master File (PSMF) and Global PSMF courses organized by DIA. The training will be delivered online from 9:00 to 13:00 (CEST) on April 17-18 and 19, 2024. 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…
We are happy to announce that Isabella Palagiano will be participating as speaker in the AEFI Safety in Clinical trials Training. The training will take place on 29th February and 5th March and will be held online, please find more information about the training in the link below: https://aefi.org/eventos/seguridad-en-ensayos-clinicos/?mc_cid=b547e1ac35&mc_eid=54a2a50032 During the 29th, Isabella will be talking about several topics related to ICSRs transmission to Eudravigilance, MHAR and FDA. **PVpharm is also organizing in-house training in pharmacovigilance for pharmaceutical companies and CROs, please contact us for further information.**
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…
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…
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…