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…

Clinical Trials Information System (CTIS) training 8-11 April 2024

Post published:April 7, 2024

The European Commission has informed that the entry into application of the Clinical Trials Regulation (CTR)

PVpharm extends the collaboration with the International AIDS Vaccine Initiative (IAVI)

Post published:March 18, 2024

We are so excited to announce the extension of our collaboration agreement 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 also work…

Pharmacovigilance training V edition, Madrid & Online 27-28 May 2024

Post published:March 16, 2024

PVpharm is leading the way in pharmacovigilance training by innovatively organizing another edition of its Pharmacovigilance Training.

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…

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.**

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…