2021 KAPAL–KHIDI Bio & Health Webinar Series는 한미생명과학인 협회 (KAPAL)와 KHIDI 미국지사 웨비나 시리즈입니다.
About this event
KAPAL 7th On-Air Webinar
(2021 KAPAL-KHIDI Webinar Series #2)
Title: Use of Real-World Data and Real-World Evidence in Drug Development
The 21st Century Cures Act established a program to evaluate the potential use of real-world evidence (RWE) to help to support the approval of a new indication for a drug approved and to help to support or satisfy post-approval study requirements. Accordingly, the FDA has been exploring the potential use of Real World Data (RWD) in regulatory decision making. This presentation will start with general overview of Real-World Data and Real-World Evidence in drug development and introduction to observational studies and causal inference. Th challenges with RWD/RWE will be discussed from multiple aspects including data quality, study design and statistical methods to adjust potential confounding. At the end of presentation, case studies will be presented.
About the presenter:
Joo-Yeon Lee, Ph.D.
Senior Statistical Reviewer, FDA
Joo-Yeon Lee, Ph.D. is a senior statistician of Division of Biometrics VII in the Office of Biostatistics in the Center for Drug Evaluation and Research at the FDA. She has received a B.S in statistics from Ewha Womans University, M.A and Ph.D. in Biostatistics from Brown University. Since joining FDA in 2007, Dr. Lee has been working as a pharmacometrics reviewer for new drug applications and a statistical reviewer for post-market drug safety studies. Dr. Lee has been playing a major role in many working groups on causal inference methods within the FDA. In addition, Dr. Lee has involved in FDA-led drug safety studies utilizing sentinel data and other data source such as UK Clinical Practice Research Datalink (CPRD) as a collaborator. Dr. Lee has taught the inverse probability weighting method with a case study at causal inference workshop at FDA in November 2017 and short courses at DIA/FDA Biostatistics Industry and Regulator Forum in April 2018 and ASA Biopharmaceutical section regulatory-industry statistics workshop in September 2020. Currently, Dr. Lee has main interest in the causal inference in observational studies, especially methods for sensitivity analysis for unmeasured confounder(s) and is an active member of quantitative bias analysis working group and serves as FDA statistical collaborator of FDA-funded project that aims to evaluate methods for assessment of potential for bias due to uncontrolled confounding.
BIO KOREA has been held every year since 2006 and serving as a business platform for international bio companies. Sponsored by the Ministry of Health and Welfare, BIO KOREA is a place of practical business correspondence as well as international information and technology exchange, invigorating the bio industry. In its 15th year of bringing together various international academics, professionals, and CEOs of global bio companies to obtain, exchange, and discuss diverse affairs, through exhibition, business forum(partnering), and conference.
BIO KOREA has been providing abundant opportunities to assure competitive edges within the convergence industry centered around biotechnology. We cordially invite you to attend BIO KOREA 2021 which will be held both online (June 9-21, 2021) and on-site (June 9-11, 2021).
2020년 카팔의 온에어웨비나 시리즈에서 주제가 되었던 내용을 정리하고 한해를 마무리하며 네트워킹하는 웨비나입니다.
About this Event
안녕하세요.
어느새 2020년을 마무리하고 2021년을 기다리는 시간이 돌아왔네요.
연말연시 모든 가정과 일터에 읏음과 행복으로 가득하길 바랍니다. 2020년을 되돌아보면 예상치 않던 코비드19로 인해 우리 생활에 많은 변화와 어려움도 있었지만, 새로운 도전도 많았던 한해 같습니다.
다행히도 코비드19 백신에 초록불이 켜졌고, 치료제 개발에도 많은 좋은 뉴스들이 나오고 있으니, 앞으로는 더욱 밝은 내용의 뉴스들을 듣길 기대하며 2021년을 준비하는 마음입니다. 오랜 펜더믹 상황에 너무 마음과 몸이 지치셨겠지만, 조금 더 힘을 내어 우리 모두 건강하게 잘 이겨내길 진심으로 바랍니다.
저희 카팔은 오는 12월 29일 (화요일 미국동부시간 오후 8시,서부 오후 5시, 한국 12/30일 오전 10시 )에 제 5 회 카팔 온에어 웨비나를 개최합니다.
