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.

Lucia Matejkinova, MSc, has over 16 years of experience in pharmacovigilance and quality assurance across the pharmaceutical industry. She has held progressive leadership roles including Pharmacovigilance Director, Director of Client Quality, and Quality Assurance Director, and has served as EU/UK QPPV for pharmaceutical service providers and their clients. Lucia is a certified Level 1 PV Auditor and ISO Auditor with extensive experience in PV audits, regulatory inspections, PV System oversight, and PSMF management. She has long-term experience delivering pharmacovigilance and audit training both internally and externally and serves as a trainer for the international training associations.