Dr. Eva Kopečná works at Acino International, Switzerland as Head of Global Regulatory Affairs, Medical and Pharmacovigilance. She has spent more than 23 years in the pharmaceutical industry in different positions, starting in R&D as a medical expert, then as Head of clinical trials, and finally she moved to Regulatory Affairs where she has been building and leading different Regulatory Affairs, Pharmacovigilance and Medical Affairs teams and organizations supporting R&D, Regulatory and Pharmacovigilance activities. Eva is a Medical Doctor with 1 ^st and 2^nd degrees in Internal Medicine, in addition she holds a MSc. degree in Regulatory Affairs from Cardiff University in the UK and Ph.D. in Pharmacy from Charles University in Prague. Eva is the author of several scientific publications, including one book on GCP. Eva has been TOPRA MSc module leader or co-leader for four TOPRA modules since 2007 and is teaching in other universities on Regulatory and GCP topics. Eva is a winner of TOPRA Award in Regulatory Excellence and is currently a member of Board of TOPRA Directors.