OCT medical writer Eugenia Radkova was among the event speakers.
The presentation “Medical Writing In Russia: More Than Medical, More Than Writing” made by Eugenia covered some unique aspects of medical writing in Russia. Eugenia touched upon regulatory aspects of clinical trials in Russia and issues relevant to EU legislation. She also spoke about challenges faced by medical writers in the development of different clinical research phases (selection of study designs and reference drugs as required by local and international legislative requirements; lack of source data about efficacy of drugs available at foreign markets; lack of scientific advice; lack of transparency in local clinical trials; limited number of regulatory guidelines and instructions).
The work of a medical writer involves several activities all of which require professional broad-based knowledge: writing of study documents, regulatory consulting, and scientific consulting (study design, sample size estimation, final data review and interpretation). All this is complicated by the lack of educational programs, changing and challenging regulatory environment, huge variety of indications and designs (I-IV phases, observational studies), and limited access to local clinical trial data. Nevertheless, year by year, medical writers in OCT maintain high quality performance and excellent regulatory compliance.
OCT employs the region’s largest team of medical writing experts who are members of AMWA and EMWA, and who always strive for improvement.