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Nov 02, 2022 1:00 PM - Nov 03, 2022 5:00 PM

(Central Europe Standard Time)

Pharmacovigilance System Master File

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


Jose Alberto Ayala  Ortiz, MPharm, MSc

Jose Alberto Ayala Ortiz, MPharm, MSc

QPPV, PVpharm, 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.

Marcela  Fialova, DrMed

Marcela Fialova, DrMed

COO, iVigee Services a.s., Czech Republic

Marcela Fialova graduated from Charles University and holds a Doctorate in Medicine as well as a Bc in Healthcare Management from the University of Economics in Prague. Additionally, she has received specialized training in Pharmacoepidemiology and Pharmacovigilance at the University of London. Dr. Fialova has over 20 years of experience with all aspects of PV, and she also acted as EU/UK QPPV mainly for innovative companies, participated in integration of PV systems after acquisitions and supported development of quality management systems. She has many years of practical experience with PV systems set up, maintenance, description in PSMF as well as with description of their interactions with partner’s PV systems in SDEA.

Claire  Longman, MSc

Claire Longman, MSc

Expert Pharmacovigilance Inspector, Medicines and Healthcare products Regulatory Agency (MHRA), United Kingdom

I am a Senior GPvP Inspector at the MHRA. I have over 5 years experience as an Inspector in Pharmacovigilance and have recently taken on the role as Head of the Good Clinical Practice Compliance Team within the MHRA. Prior to joining the MHRA I worked in Industry where I held various roles within Pharmacovigilance and Medical Information.

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