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Virtual

Sep 28, 2026 1:00 PM - Sep 29, 2026 5:00 PM

(Central European Summer Time)

Pharmacovigilance System Master File

This virtual live training course covers essential concepts and guidance about the Pharmacovigilance System Master File (PSMF).

Faculty

Jose Alberto Ayala  Ortiz, MBA, MSc

Jose Alberto Ayala Ortiz, MBA, MSc

CEO, PVpharm S.L., Spain

José is an expert in the field of Pharmacovigilance and Drug Safety. He has experience both from the Regulatory (Danish Medicines Agency), and from the Pharmaceutical Industry, where he has been responsible for Pharmacovigilance IT systems, databases and electronic transmissions. He has been training EVWeb and XEVMPD training courses since 2004, and collaborates in the development of these training courses. He provides also EU QPPV services and local QPPV services in Spain for Pharmaceutical Companies.

Andrew  Underwood

Andrew Underwood

GPvP inspector, Medicines and Healthcare products Regulatory Agency (MHRA), United Kingdom

Andrew Underwood is a Pharmacovigilance Inspector at the Medicines & Healthcare products Regulatory Agency (MHRA). He conducts statutory inspections of pharmacovigilance systems to assess compliance with the UK pharmacovigilance regulatory framework. His work includes the inspection of Pharmacovigilance System Master Files (PSMFs), sources of safety information, and adverse drug reaction (ADR) reporting processes. Prior to joining the MHRA, Andrew worked as a medical doctor within the National Health Service. He brings both clinical and regulatory perspectives to medicines safety and pharmacovigilance oversight.

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