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…

IV PV TRAINING: unique pharmacovigilance training experience

Post published:July 11, 2023

PVpharm led the way in pharmacovigilance training by innovatively organizing another edition of its Pharmacovigilance Training. This 3rd edition was hosted on May, 2022.

Faculty at Signal Management training by DIA June 2023

Post published:June 16, 2023

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…

José Alberto Ayala Ortiz to participate in the AEFI Symposium 2023

Post published:June 1, 2023

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/

Online EVWeb training 22-26 May 2023

Post published:May 17, 2023

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…

Online XEVMPD training 10-12 May 2023

Post published:April 27, 2023

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…

Training Online XEVMPD for SPONSORS 4-5 May 2023

Post published:April 27, 2023

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).

DIA Pharmacovigilance System Master File (PSMF) and Global PSMF virtual courses (18-20 April 2023)

Post published:April 12, 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 9:00 AM to 1:00 PM (CEST) on April 18 to 20, 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 by a Competent…

Online XEVMPD training 13-15 and Sponsors XEVMPD 16-17 Feb 2023

Post published:January 16, 2023

José Ortiz will be participating as a trainer in the next XEVMPD training on 14-16 Feb 2022. The training will focus on explaining the guidance and specifically the mandatory data elements necessary for the electronic submission of information on medicinal products.