myrwdРеальная клиническая практика: данные и доказательстваReal-World Data & Evidence2782-3784Publishing House OKI10.37489/2782-3784-myrwd-7UJOEUBmyrwd-9Research ArticleРЕГУЛЯТОРНАЯ СИСТЕМАREGULATORY SYSTEMДанные реальной клинической практики: обобщенные регуляторные подходы ЕС и ЯпонииReal-world data: general regulatory approaches in the EU and Japanhttps://orcid.org/0000-0002-6448-6973БорзоваМ. А.BorzovaM. A.

Борзова Мария Анатольевна – советник 

Москва

Borzova Maria A. – Counsel 

Moscow

maria.borzova@gmail.comАдвокатское бюро «Трубор»Россия"Trubor" Law FirmRussian Federation202223022022211116Copyright © Борзова М.А., 20222022Борзова М.А.Borzova M.A.Данная работа распространяется под лицензией Creative Commons Attribution 4.0.This work is licensed under a Creative Commons Attribution 4.0 License.https://www.myrwd.ru/jour/article/view/9

В статье описываются регуляторные подходы к сбору, анализу и использованию данных реальной клинической практики, которые применяются в Европейском союзе и Японии.

The article describes the regulatory approaches to the collection, analysis and usage of real-world data applied in the European Union and Japan.

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The authors declare that there are no conflicts of interest present.