Zuzana Vinterova received her PhD in Biochemistry from Charles University in Prague and she worked as a researcher at the Institute of Organic Chemistry and Biochemistry within the Czech Academy of Sciences, focusing on the major virulence factors of pathogenic yeasts (Candida spp.). Zuzana has joined PharmInvent (rebranded to PrimeVigilance in 2018) as a scientific specialist and medical writer and has now over 10 years of experience in medical writing of pharmacovigilance (PSUR/PBRER, DSUR, ACO, RMP) as well as regulatory science documents, needed throughout the full life-cycle of medicinal products.

Núria Semis-Costa is a biochemist (Universitat Autònoma de Barcelona) with a MSc in Pharmacovigilance (Universitat de Barcelona). After working in the industry in the field of blood products, she joined the EMA as a Risk Management Specialist in 2015, where she works in the areas of rheumatology, immunology and advanced therapies. Núria is also involved in initiatives related to risk management of biosimilars and medicines in pregnancy, the maintenance of the RMP template and the update of GVP XVI.

PV professional with immense experience with critical PV processes gained through execution as well as its successful leadership and management. The key areas of Jan’s expertise are strategic consulting on full PV outsourcing including expert advice and guidance on the implementation of AI-powered safety systems, Safety data mining in global databases, ICSR Management, EV and XEVMPD maintenance, EU QPPV activities, signal management, PSMF development/maintenance, medical writing, and audits/inspections.