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…

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

DIA Pharmacovigilance System Master File (PSMF) virtual course (2-3 November 2022)

  • Post published:October 25, 2022

José Ortiz will be participating as a trainer together with Marcela Fialova and Claire Longman, MSc Interim Head of GCP and Senior Pharmacovigilance Inspector at the Medicines and Healthcare products Regulatory Agency (MHRA), United Kingdom in the Pharmacovigilance System Master File (PSMF) course organized by DIA. The training will be delivered online from 1:00 PM to 5:00 PM (CEST) on November 2 to 3, 2022. This virtual live training course covers essential concepts and guidance about the Pharmacovigilance System Master File (PSMF). This key document describes the company’s pharmacovigilance system, supporting, and documenting its compliance with the requirements laid down…

Continue ReadingDIA Pharmacovigilance System Master File (PSMF) virtual course (2-3 November 2022)

DIA Pharmacovigilance QMS virtual course (19-22 September 2022)

  • Post published:September 13, 2022

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 01:30 PM (CEST) on September 19 to 22, 2022. 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 SystemQMS OverviewPV…

Continue ReadingDIA Pharmacovigilance QMS virtual course (19-22 September 2022)

DIA Pharmacovigilance QMS virtual course (25-28 January)

  • Post published:January 19, 2022

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 01:30 PM (CEST) on January 25 to 28, 2022. 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 SystemQMS OverviewPV…

Continue ReadingDIA Pharmacovigilance QMS virtual course (25-28 January)

DIA Pharmacovigilance QMS virtual course (21-24 September)

  • Post published:September 14, 2021

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 1:30 PM to 6:00 PM (CEST). 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 SystemQMS OverviewPV SystemSystem, Processes, Quality DocumentsPSMF and PV…

Continue ReadingDIA Pharmacovigilance QMS virtual course (21-24 September)

QMS virtual course – 26-29 January 09.00-13.30 CEST

  • Post published:December 9, 2020

José Ortiz will be participating together with Brian Edwards in the faculty of the QMS training course organized by DIA. At the conclusion of this virtual live course, participants will be able to: • Describe how to design, develop, and manage a Quality System related to Pharmacovigilance System • Explain the components of the Pharmacovigilance Quality Manual • Describe the process for the development and maintenance of the Pharmacovigilance System Master File • Analyze how the Pharmacovigilance Quality System integrates with the Pharmacovigilance System • Discuss the development, maintenance, and quality oversight of Pharmacovigilance SOPs and Pharmacovigilance related documents, including…

Continue ReadingQMS virtual course – 26-29 January 09.00-13.30 CEST

Jose Ortiz at the European Pharmacovigilance Congress 2020

  • Post published:November 19, 2020

We are delighted to announce that José Alberto Ayala Ortiz, PVpharm's CEO, will be participating in the European Pharmacovigilance Congress 2020 organized by the Pharma Education Center. You can find the link to the Congress here: https://www.pharmaeducationcenter.it/wp-content/uploads/2020/11/EUPV_Final_2020-1.pdf José will be participating in two round tables on the 27th of November:-Eudravigilance EVDAS updates-Local VS Global PV regulations Please see some screenshots of the sessions: PVpharm is also organizing in-house trainings in pharmacovigilance for pharmaceutical companies and CROs, please contact us for further information.

Continue ReadingJose Ortiz at the European Pharmacovigilance Congress 2020