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) |
링크 |
|
2024/10/02 |
Causal inference chapter 1 ~ 2 |
||
2024/10/16 |
Causal inference chapter 3 ~ 4 |
||
2024/10/23 |
FRAMEWORK FOR FDA’S REAL-WORLD EVIDENCE PROGRAM |
||
2024/10/30 |
FRAMEWORK FOR FDA’S REAL-WORLD EVIDENCE PROGRAM |
||
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) |
||
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) |
||
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)] |
||
2024/12/04 |
MHRA guideline on RCT using RWD to support regulatory decisions |
이현빈 |
|
2024/12/18 |
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 |
||
2024/01/08 |
Real-World Evidence: Considerations Regarding Non-Interventional Studies for Drug and Biological Products Guidance for Industry |
||
2024/01/15 |
Use of Real-World Evidence to Support Regulatory Decision-Making for Medical Devices Guidance for Industry and Food and Drug Administration Staff |
||
2025/01/22 |
의료기기의 실사용증거 적용에 대한 가이드라인 (식약처) |
||
2025/02/05 |
의료기기의 실사용증거 적용에 대한 가이드라인 (식약처) |
김가경 |