국내 의료기기 기업의 글로벌 시장 진출 경쟁력 확보 및 글로벌 네트워크 강화를 위하여 Global Medical device Key Opinion Leaders (이하 “GMKOL”) 전문위원을 위촉하고자 합니다. 이에 의료기기 해외진출 정보 및 컨설팅 제공이 가능한 권역별/ 분야별 ‘GMKOL 전문위원’을 다음과 같이 공개 모집 하오니 의료기기 해외진출 전문가의 많은 참여를 바랍니다.
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 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).
실리콘밸리K-MOVE 기술인력 커리어페어 (Silicon Valley K-Move Virtual Career Fair)
Date and Time
2021년 6월 9일 17:00~18:00 (PST)
주최 : 주샌프란시스코 총영사관, 코트라 실리콘밸리 무역관
김은주 UX Desinger @Google
박영희 Senior Director @ SK hynix
김재범 Managing Director @ Samsung Biologics
김영교 Staff Product Designer @ Lyft
참가신청(eventbrite 사전신청 필수) : https://bit.ly/331K3QY
취업설명회에는 글로벌기업 SK hynix, Samsung Biologics, Google, Lyft 의 현직에 계신 관계자분들을 Zoom으로 모시어 실리콘밸리가 원하는 인재상, 글로벌 IT 회사의 채용 과정과 회사 문화 등에 대해 들어보는 시간을 가질 예정이니, 취업을 준비하는 청년들의 많은 관심과 참여 바랍니다!
이번 행사는 사전 신청이 필수 입니다.
eventbrite 통해 등록하시는 분들께 한하여 zoom link를 보내드릴 예정이니 신청 바랍니다.
연사님들께 궁금한 점이 있으시면 질문사항을 firstname.lastname@example.org로 보내주시기 바랍니다.
취업설명회와 더불어, 채용을 전제한 1:1 취업상담회도 예정되어 있습니다! 이번 상담회에 참가하는 회사 및 포지션 정보는 아래 케이무브 페이스북을 통해서 확인해보시기 바랍니다.
취업상담회 1:1화상면접을 원하시는 분은, email@example.com로 지원하시는 회사명을 제목에 명기하시어 이력서(+커버레터)를 보내주시기 바랍니다. (예: (Grandlife) 회사지원))
본 행사와 관련하여 궁금한 점이 있으신 분은 코트라 실리콘밸리 무역관 서지원 과장, 김효정 대리에게 연락주시기 바랍니다. (firstname.lastname@example.org)
코트라 실리콘밸리 무역관
The Asian Fund for Cancer Research (AFCR) is pleased to be presenting the 2021 BRACE Award Venture Competition. Semi-finalists will be selected, each of whom will receive widespread exposure and beneficial feedback from a blue-ribbon judging committee. Subject to due diligence and negotiation, the winning company will receive US$300,000 in investment funding from AFCR. Cash awards of US$5,000 and $3,000 will be granted to 2nd and 3rd place competitors, respectively. Click here to download the flyer!
Format & Timeline
- Submit an online application:
- Each applicant must submit an online application consisting of summary details, a short video and a presentation deck summarizing the business plan.
- Application deadline: Tuesday, 1 June 2021, 11:59 PM Hong Kong Time
- Selection of Semi-Finalists:
- Submitted applications will be screened by AFCR personnel. Only submissions that demonstrate cancer mitigation technology, business potential and professionalism will be approved.
- A highly qualified selection committee will review approved applications and determine semi-finalists based on the overall quality of responses.
- Semi-finalists will be announced over two weeks before the pitch competition, by e-mail communication to all approved applicants and online to general public.
- Semi-finalists’ short video clips will be voted on by the public in determining the BRACE Award Venture Competition’s “Best Public Communicator” and generating buzz for the event. Cash award of US$2,000 will be grated to the top voted Semi-Finalist!
- Virtual Competition and Selection of Finalists
- Semi-finalists chosen are invited to pitch to a judging committee in a series of private presentations on a To Be Determined (TBD) 2021 date—morning, Hong Kong Time. After the conclusion of the pitch competition, top competitors will be highlighted.
- PowerPoint or PDF presentation formats are required, and must be delivered—verbally and visually—in English. Presenters are required to be available well in advance of their predesignated time slot, and time limit will be strictly enforced.
- Selection of Winner and Announcement of Investment
- AFCR will perform detailed due diligence on and communicate with the semi-finalists, in order to determine allocation of US$300,000 in AFCR investment into the business deemed to have the strongest potential for return and cancer patient impact.
- Announcement of investment will be made in person to the winner at the BIOHK2021, and online to general public.
- Application must be submitted by a senior executive of an start-up with promising and innovative oncology technologies – therapeutic, diagnostic, preventive, digital health solutions or others – for those cancers prevalent in Asian populations. The individual could be a founder, president, chief executive officer, chief scientific officer, chief medical officer or chief technology officer.
- Applicant must demonstrate track record of milestone achievement, such as, but not necessarily limited to, government or foundation grants, patents, successful clinical trial phases, commercial exits, etc.
- No fee to apply.
If you have questions, need more information or are interested in sponsoring this or future BRACE Award Venture Competitions, please contact:
AFCR Senior Director of Global Programs & Communications