인과추론과 Real World Evidence (RWE) 가이드라인을 공부합니다. 자료는 깃허브 페이지 형태로 공유할 계획입니다.
아래는 깃허브 페이지 링크입니다. https://causalinferencelab.github.io/Bridging-Causal-Inference-and-Real-World-Evidence-A-Study-of-FDA-and-Other-Regulatory-Guidelines/intro.html
💡 주차별 진행계획은 러너(스터디원)분들과 협의에 의해 변경될 수 있습니다.
| 날짜 | 내용 | 발표자 | 매체 |
|---|---|---|---|
| 2024/09/25 | OT (스터디 소개, 방향 논의, Ice breaking) | 박상호 | 링크 |
| 2024/10/02 | Causal inference chapter 1 ~ 2 | 박상호 | 링크 |
| 2024/10/16 | Causal inference chapter 3 ~ 4 | 최재윤 | 링크 |
| 2024/10/23 | FRAMEWORK FOR FDA’S REAL-WORLD EVIDENCE PROGRAM | 곽수영 | 링크 |
| 2024/10/30 | FRAMEWORK FOR FDA’S REAL-WORLD EVIDENCE PROGRAM | 전인영 | 링크 |
| 2024/11/06 | General Principles on Plan, Design and Analysis of Pharmacoepidemiological Studies That Utilize Real-World Data for Safety Assessment of Medicines (ICH M14 guideline) | 박상호 | 링크 |
| 2024/11/13 | General Principles on Plan, Design and Analysis of Pharmacoepidemiological Studies That Utilize Real-World Data for Safety Assessment of Medicines (ICH M14 guideline) | 김청수 | 링크 |
| 2024/11/20 | Reflection paper on use of real-world data in non-interventional studies to generate real-world evidence - Scientific guideline [RWE Reflection paper - draft for public consultation (europa.eu)] | 곽수영 | 링크 |
| 2024/11/27 | MHRA guideline on RCT using RWD to support regulatory decisions | 이현빈 | 링크 |
| 2024/12/04 | Considerations for the Use of Real-World Data and Real-World Evidence to Support Regulatory Decision-Making for Drug and Biological Products Guidance for Industry | 이승미 | 링크 |
| 2024/12/11 | Real-World Evidence: Considerations Regarding Non-Interventional Studies for Drug and Biological Products Guidance for Industry | 정현우 | 링크 |
| 2024/12/18 | Use of Real-World Evidence to Support Regulatory Decision-Making for Medical Devices Guidance for Industry and Food and Drug Administration Staff | 차현실 | 링크 |
| 2025/01/08 | 의료기기의 실사용증거 적용에 대한 가이드라인 (식약처) | 박상호 | 링크 |
| 2025/01/15 | 의료기기의 실사용증거 적용에 대한 가이드라인 (식약처) | 박상호 | 링크 |
| 2025/01/22 | Real-World Data: Assessing Electronic Health Records and Medical Claims Data To Support Regulatory Decision-Making for Drug and Biological Products; Guidance for Industry | 김태헌 | 링크 |
| 2025/01/29 | Real-World Data: Assessing Electronic Health Records and Medical Claims Data To Support Regulatory Decision-Making for Drug and Biological Products; Guidance for Industry | 박상호 | 링크 |