본 책자는 (재)원주의료기기산업진흥원이 수행하는 ‘의료기기 임상전문가 양성사업’의 일환으로 제작하였으며, 무단 복제 및 배포를 금합니다.

1. MDCG 2024-15 ......................................................................................................01
2. IMDRF_WGN41(2017).........................................................................................09
3. IMDRF_WGN57(2019).........................................................................................57
4. IMDRF_WGN55(2019).........................................................................................75
5. IMDRF_WGN65(2021).........................................................................................89
6. Collection of Race and Ethnicity Data in Clinical Trials and Clinical Studies for FDA ................................................. 111
7. Collection of Race and Ethnicity Data in Clinical Trials ......................... 129
8. ICH E17................................................................................................................... 159
9. ICH E10................................................................................................................... 195
10. ICH E7................................................................................................................... 247
11. ICH E8................................................................................................................... 259
12. ICH E9................................................................................................................... 301
13. ICH E9-R1............................................................................................................ 365