Category: Event

보건복지부 메디컬코리아 거점 공관 지원사업으로 개최하는 본 행사는 주미대사관이 주최하고, KAPAL과 진흥원 미국지사에서 공동으로 주관하는 바이오헬스 한국기업 미국진출 전략 세미나입니다.

주미대사관(김상희 공사참사관 총괄) 주최, KAPAL과 진흥원 미국지사 공동 주관

바이오헬스 한국기업 미국진출 전략 온/오프라인 세미나

• Online Webinar Registration: https://bit.ly/2SFGnTq

• Onsite Seminar (@ 주미대사관) Registration: contact@kapal.org

시간
미국 (동부): July 15, 2021 (Thr) 7:00 – 8:00 PM EDT (1부, Dinner & Networking)
8:00 – 9:50 PM EDT (2부, Seminar – Online 생중계)
한국: 7월 16일 (금요일) 9:00 – 10:50 AM KST (Online webinar)

장소
워싱턴 DC 주미한국대사관 1층 대회의실
2450 Massachusetts Ave NW, Washington, DC 20008
* On site Seminar는 CDC(미국 질병통제예방센터) 기준으로 코로나 백신 완전 접종자에 한해 현장 행사 참석 예정입니다.

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.

7th KAPAL On-Air webinar materials

2021 KAPAL–KHIDI Bio & Health Webinar Series #1

When: 04/29/2021, 9:00pm – 10:30pm (EST)
04/29/2021, 6:00pm – 7:30pm(PST)
04/30/2021, 10:00am – 11:30am(KST)

Speaker : Stanford Jhee (Corporate Vice President, Scientific Affairs, Parexel International)

Title: Accelerating Global drug development: Ethnobridging strategies for Asia.

Objectives

1. Define and understand ethnic sensitivity issues in drug development
2. Regulatory updates on Japan and China clinical trials and product registration
3. Clinical pharmacology strategies for identifying ethnicity factors

6th KAPAL On-Air webinar materials will be posted later.