Martina Nora Odložilíková, MPharm
Pharmacist by education, Nora gained professional experience in Zentiva, Prague, Czech Republic, in the analytical R&D. She participated in various levels of pharma development, e.g. development/validation/transfer of analytical methods for numerous new products, dissolution method development, stability testing, portfolio care etc. She was involved in implementing CTD for Module 3 texts, and responded to hundreds of questions in deficiency letters of Registration Authorities, thus contributing to successful marketing authorizations. Later in her career she became a professional in the field of Regulatory Sciences by carrying out a considerable variety of tasks (including medical writing, impurities assessment, in vitro data analysis, briefing packages for SA, biowaivers, IVIVC) at Pharminvent. Together with Vit, she built up the format for BCS-based biowaivers acknowledged by a number of European Authorities.
As an independent consultant, Nora specializes predominantly in the CMC (Chemistry, Manufacture, Control) part of pharma development. She advises on the levels of detail to include in the regulatory documents like ASMF, CEP, IMPD etc. Nora likes discovering new paths through the regulated area, solving unexpected issues, looking for context.