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Bridging Causal Inference and Real-World Evidence: A Study of FDA and Other Regulatory Guidelines

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 목표와 학습 내용

💡 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
2024/11/27 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
2024/12/04 MHRA guideline on RCT using RWD to support regulatory decisions 이현빈 링크
2024/12/11 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
2024/12/18 Real-World Evidence: Considerations Regarding Non-Interventional Studies for Drug and Biological Products Guidance for Industry 정현우 링크
2024/01/08 Use of Real-World Evidence to Support Regulatory Decision-Making for Medical Devices Guidance for Industry and Food and Drug Administration Staff 차현실 링크
2025/01/15 의료기기의 실사용증거 적용에 대한 가이드라인 (식약처) 박상호 링크
2025/01/22 의료기기의 실사용증거 적용에 대한 가이드라인 (식약처) 박상호 링크
2025/02/05 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
2025/02/12 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

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