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 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 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.