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Virtual Event

2023年11月02日 (木) 午後 1:00 - 2023年11月03日 (金) 午後 5:00

(Central Europe Standard Time)

4051 Basel, Switzerland

Pharmacovigilance System Master File

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.

Anastasia  Daskajiannis St John

Anastasia Daskajiannis St John

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

Anastasia has been working at the MHRA for 5 years. Her PV experience ranges from product information quality and safety variations, ICSR case processing, signal assessment and management, as well as governance. More recently Anastasia has joined the PV inspector team at the MHRA to focus on compliance. Notable career highlights includes appointment as one of the first COVID-19 vaccine safety assessors monitoring the benefit-risk profile post vaccine roll-out. Her academic background is in biochemistry.