The EAEU & CIS Pharmaceutical Forum
The EAEU & CIS Pharmaceutical Forum 2018 was held in Moscow on February 27-28 with the sponsorship of “Sciencefiles” LLC. On the first day of the Forum Yana Bulgakova, “Siencefiles” key medical writer, made a report on the format of Common Technical Document (CTD), which is a compulsory style guide requirement for a registration dossier submitted to a regulatory authority. The report highlighted the role and competence of a medical writer in creation of the registration dossier in CTD format, as well as the procedure of dossier design. The main difficulty to the work with CTD is in processing and compartmentation of huge information in the strict format according to a modular approach. Yana Bulgakova emphasized that modules preparation was a hard procedure requiring well-coordinated team work. Thus, “Sciencefiles” project team has included: a project manager, a literature reviewer, a medical writer of a preclinical part, a medical writer of a clinical part, linguist proofreader, a medical advisor and a librarian. Moreover, the definition and appropriate usage of the term “medical writer” were specified as well as its translation into Russian language was suggested.