Blanka Hirschlerová

Head of Department of Pharmaceutical Assessment, State Institute for Drug Control

Blanka Hirschlerová is working in the State Institute for Drug Control in Prague since October 1992 as pharmaceutical assessor. Currently she holds position as head of the Department of Pharmaceutical Assessment of Chemical and Herbal Drugs. She studied at the Faculty of Chemical Engineering of the Institute of Chemical Technology, Prague specializing in Analytical and Physical Chemistry.

Since February 2020 Blanka is chairing the CHMP/CVMP Quality Working Party. She has been actively participating in QWP for many topics during years. She is also a co-opted member for quality issues at CHMP.

She participated on several ICH topics as EU representative, since 2005 on Q8 (Pharmaceutical development) and then further on an addendum of Q8, in 2011 on the final work on Q11 (Pharmaceutical development of active substance) and during 2014 and 2016 CTD-Q/M4Q (revision of CTD granularity document) and recently she is participating in ICH QDG.