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8th KAPAL On-Air Webinar (Sep 9, 2021, 5 PM – 6:30 PM PST / Sep 10, 2021, 9 AM – 10:30 AM KST) – Digital Health & FDA Guidance (KAPAL California Webinar series 1)
「포스트 코로나 시대 바이오헬스 분야 한국기업 미국진출 전략」 온/오프라인 세미나 (Washington DC, 주미한국대사관) sebinar materials (Presentation slides and recordings)
지난 7월 15일에 「포스트 코로나 시대 바이오헬스 분야 한국기업 미국진출 전략」를 주제로 보건복지부 메디컬코리아 거점 공관 지원사업으로 주미대사관이 주최하고, KAPAL과 진흥원 미국지사에서 공동으로 주관하는 바이오헬스 한국기업 미국진출 전략 세미나가 진행되었습니다.
회원 여러분들의 많은 관심과 도움으로 Online Webinar에 280여분과 Washington DC, 주미한국대사관 Onsite seminar에 30여분이 참석하셔서 많은 질의 응답이 진행되는 등 성황리에 완료 되었습니다.
관련하여 많은 요청에 따라 해당 seminar materials (Presentation slides and recordings)은 아래 링크를 통하여 다운로드하시거나 재 시청하실 수 있습니다.
도움 주시고 참여해주신 모든 분들께 다시 한번 감사의 인사를 드립니다.
○ 미국 내 바이오헬스 주요 클러스터의 특장점 소개: 박상태 COREE 미국법인장
○ 미국 내 법인 설립 및 절차: 김한신 변호사
○ 한국기업의 미국 진출 사례
동부지역: 양세환 네오이뮨텍 대표
서부지역: 김현종 ASTA 미국법인장
Full Seminar Recording (including Intro and Q&A)
「포스트 코로나 시대 바이오헬스 분야 한국기업 미국진출 전략」 온/오프라인 세미나 (Washington DC, 주미한국대사관)
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.
7th KAPAL On-Air Webinar (June 24, 2021, 9:00 – 10:30 PM EST)
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
BIO KOREA 2021 (June 9 (Wed) – 21 (Mon), 2021)
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).
