Experience

State Institute for Drug Control

• Pharmaceutical Manufacturing
• 1 - 100 Employee

• Head of Non-clinical and Bioanalysis Assessment Unit

  • Feb 2021 - Present

• Non-clinical Assessor and Toxicologist, Preclinical and Clinical Documentation Assessment Dpt.

  • Jul 2016 - Present

  Non-clinical Assessor for centralised (CP), mutual recognition (MRP), decentralised (DCP) and national regulatory procedures European and national scientific advice Toxicologist (risk/safety assessments) Member of the Safety Working Party (SWP) of the EuropeanCommittee on Human Medicinal Products (CHMP) at the European MedicinesAgency (EMA) since September 2012Non-clinical Expert for the Paediatric Committee's (PDCO's) Non-clinical Working Group (NcWG) at the European Medicines Agency (EMA) since January 2018European Registered Toxicologist (ERT) Show less

• Deputy Head of the Preclinical and Clinical Documentation Assessment Dpt.

  • Jul 2015 - Nov 2017

• Assessor of pre-clinical and clinical documentation for drug marketing authorisation

  • Apr 2012 - Jul 2016

  Non-clinical Assessor for centralised (CP), mutual recognition (MRP), decentralised (DCP) and national regulatory procedures European and national scientific advice Toxicologist (risk/safety assessments) Clinical Assessor (CNS indications)for centralised (generics) procedures and mutual recognition (MRP), decentralised (DCP) and national regulatory procedures, European and national scientific advice