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.

Claire is the Expert Pharmacovigilance Inspector at the MHRA. She has 10 years experience at the MHRA holding various positions within the MHRA Compliance Teams. Claire has led multiple high profile inspections as well as given a variety of presentations and talks at numerous events in the UK and overseas. In Claire's current role as the Expert Inspector, she is responsible for developing the strategy of the GPvP Compliance Team and aligning this with other GxPs across the MHRA. Prior to joining the MHRA Claire worked in Industry where she gained experience in a number of aspects of Pharmacovigilance and Medical Information.