PVpharm at Upcoming EVWeb Training – This December!

Post published:November 28, 2024

José Ortiz, CEO of PVpharm, will be participating as a trainer in the upcoming EVWeb training, scheduled from Monday, 02 December to Friday, 06 December 2024. This comprehensive online training will take place all day and is tailored for professionals involved in reporting and analyzing suspected adverse reactions. About the Training EudraVigilance is the EU's system for managing and analyzing information on adverse reactions to medicines authorized or studied within the European Economic Area (EEA). This training focuses on the mandatory use of the ISO Individual Case Safety Report (ICSR) standard, based on ICH E2B(R3) modalities, which became effective on…

Lecturer at the Global Pharmacovigilance Congress – Global PV Society

Post published:November 16, 2024

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.

DIA Pharmacovigilance System Master File (PSMF) and Global PSMF virtual courses (26-27 and 28 November 2024)

Post published:November 4, 2024

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…

Faculty at Signal Management training by DIA November 2024

Post published:November 4, 2024

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…

DIA Pharmacovigilance QMS virtual course (16 – 19 September 2024)

Post published:August 2, 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 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…

Programa Especializado Buenas Prácticas de Farmacovigilancia

Post published:July 13, 2024

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.

DIA Pharmacovigilance System Master File (PSMF) and Global PSMF virtual courses (16-17 and 18 April 2024)

Post published:April 7, 2024

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…

Isabella Palagiano to participate as speaker in the AEFI Safety in Clinical Trials Training

Post published:February 20, 2024

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.**

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…

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…