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

  • Post published:November 4, 2024

JosĂ© 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…

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

  • Post published:August 2, 2024

JosĂ© 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…

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

  • Post published:April 7, 2024

JosĂ© 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…

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DIA Pharmacovigilance QMS virtual course (27 February-1 March 2024)

  • Post published:January 27, 2024

JosĂ© 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…

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DIA Pharmacovigilance System Master File (PSMF) and Global PSMF virtual courses (30 October and 2-3 November 2023)

  • Post published:October 30, 2023

JosĂ© 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…

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Pharmacovigilance Webinar – Audit and Inspection (8 September 2023)

  • Post published:September 8, 2023

JosĂ© 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.**

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DIA Pharmacovigilance QMS virtual course (18-21 September 2023)

  • Post published:August 28, 2023

JosĂ© 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…

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

  • Post published:April 12, 2023

JosĂ© 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…

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

  • Post published:October 25, 2022

JosĂ© 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…

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PVpharm at Farmaforum 2022 (Video)

  • Post published:October 18, 2022

PVpharm participated in the 2022 edition of FARMAFORUM. PVpharm presented their services. We created a VIDEO that you can see below. Pharmacovigilance and quality services GVP, GCP, GDP and GMP: As a Pharmacovigilance service provider, PVpharm offers a full range of PV services for the pharmaceutical industry, sponsors of clinical trials and other service provider companies. PVpharm also provides a risk-based Pharmacovigilance Audit Service, which focuses on the areas of highest risk to an organisation’s pharmacovigilance system, taking into account applicable local regulatory requirements. Our approach is risk and process based, our objective is to improve your pharmacovigilance system in order to…

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