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…

Lecturer at the International Pharma Industry Congress – LATAM 2023

Post published:December 8, 2023

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.

Defafios actuais de Farmacovigilancia

Post published:November 27, 2023

José Alberto Ayala Ortiz, CEO of PVpharm participated in the 1st edition of the Conference organized by OWL Pharma, Desafios Actuais de Farmacovigilancia, held in Lisbon on the 22nd of November 2023. José provided insight about Signal Detection in Pharmacovigilance and the use of EVDAS. Please check OWL Pharma website for more information: https://www.owlpharma.pt/news/o-futuro-de-farmacovigilancia-1a-edicao-desafios-atuais-de-farmacovigilancia **PVpharm is also organizing in-house training in pharmacovigilance for pharmaceutical companies and CROs, please contact us for further information.**

Online XEVMPD training 27-29 November 2023

Post published:November 24, 2023

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…

Online EVWeb training for SPONSORS 27-29 November 2023

Post published:November 23, 2023

José Ortiz, CEO of PVpharm will be participating as a trainer, in the next EVWeb training specifically targeted for SPONSORs of Clinical trials on 27-29 November 2023. The training will be delivered online in the morning time (9:00-13:00 CET). The training is targeted to: -Sponsors who have to report and analyse suspected adverse reactions in the pre- 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…

José Alberto Ayala Ortiz to participate as speaker in the AEFI Pharmacovigilance in Social Networks Training

Post published:November 2, 2023

We are happy to announce that José Alberto Ayala Ortiz, PVpharm's CEO will be participating as speaker in the AEFI Pharmacovigilance in Social Networks Training. The training will take place on Monday 6th November from 16:00 to 19:00, please find more information about the training in the link below: https://aefi.org/eventos/farmacovigilancia-en-la-era-digital/?mc_cid=ddb97c2046&mc_eid=54a2a50032 During the session, José will be talking about several topics related to Pharmacovigilance and handling of safety related information detected in Social Networks.

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…

Development substance data request from EMA – Action required by 01-09-2023

Post published:July 14, 2023

As an owner of development substance data in the Extended EudraVigilance Medicinal Product Dictionary (xEVMPD), the EMA is requesting an action by 1st of September 2023. For the unmapped substance data, the EMA is asking organizations to raise a request for the creation of new approved substance data. This activity requires time, expertise and experience with the xEVMPD. In PVpharm we are experts in xEVMPD, as well as xEVMPD trainers. We can help you to perform this activity on time. Please contact us.