Justyna Malinowska

* RESPONSIBLE FOR module 3 (CTD) assessment in the Unit for Documentation Assessment of Herbal, Homeopathic and Galenical Medicinal Products ** MAIN TASKS INCLUDE: assessment, in accordance with current EU quality requirements for medicines, of pharmaceutical/quality data provided in applications for a marketing authorisation or applications for a variation to an existing marketing authorisation *** MY WORK INVOLVES: preparation of assessment reports, correspondence with applicants

* TRAINEE PLACEMENT within the team for food contact materials

* RESPONSIBLE FOR coordination of variations to marketing authorisations in the Unit for Variations to Herbal, Homeopathic and Galenical Medicinal Products ** MAIN TASKS INCLUDED: validation of submitted documentation in compliance with current national legislation, interactions with internal/external experts, applicants, other national authorities, preparation of official regulatory documents in the end of the process *** OTHER TASKS also included assessment of module 3 (CTD)

STUDENT TRAINING in ‘Chemical and Analytical Development/Analytical R&D’ Department: LC-MS analysis in the determination of impurities in drug substances

STUDENT TRAINING: quality control of medicines and pharmaceutical production process under GMP