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Virtual

Apr 18, 2023 9:00 AM - Apr 19, 2023 1:00 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).

Faculty

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.

Sarah  Gomersal

Sarah Gomersal

GPvP Inspector , Medicines and Healthcare Products Regulatory Agency (MHRA), United Kingdom

Sarah joined the MHRA GPvP Inspectorate in 2019. During this time she has led a significant number of inspections and been involved in the training of new inspectors. Prior to this, Sarah worked within the MHRA for three years as a Senior Pharmacopoeial Scientist for the British Pharmacopoeia, writing monographs for medicinal chemical products and managing analytical method development with the BP Laboratory in support of the standard setting process. She was also responsible for the preparation of summary reports and recommendations for Expert Advisory Groups and Panels of Experts of the British Pharmacopoeia. Sarah has a First Class Honours degree in Biomedical Sciences from The University of Manchester.

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