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Si2C "Symposium: Statistical considerations of medical device clinical trials conducted for market approval"
Symposium: Statistical considerations of medical device clinical trials conducted for market approval
活動主旨：
中、高階風險等級的醫材產品商品化發展過程中，因醫材產品的多樣性，使得臨床試驗設計與統計考量的課題更加複雜化且重要。為符合上市法規的要求，臨床試驗上的統計考量，是醫材商品化的過程中至關重要的課題。
為增進Si2C所輔導的團隊及相關醫材產業對此課題能有更深的瞭解，Si2C繼七月初所舉辦的醫材臨床試驗法規的訓練後，於11/2與11/4兩日，邀請呂大鐘博士蒞臨講授醫材臨床試驗上的統計考量。呂大鐘博士以統計學的訓練背景，在US FDA CDRH擔任多年的 Statistic Reviewer，對醫材臨床試驗上的統計考量有豐富的經驗，相信對與會者將有很大的助益。
邀請專家：呂大鐘博士 Dr. Hollington Lu, US FDA CDRH (Retired)
2009 –present
Consultant to CROs on statistical and regulatory issues of the medical devices submission for FDA approval.
4/1990 – 1/2009 Mathematical Statistician, Division of Biostatistics, Office of Surveillance and Biometrics, Center for Device and Radiological Health (CDRH), FDA. Responsible for statistical tasks on the medical devices clinical trial, which include protocol review of pre-marketing study design, endpoints, sample size and statistical analysis of the device trial submissions, IDE, 510(K) and PMA. Therapeutic areas include: Cardiovascular, Ophthalmology, Orthopedics, OB/GYN and Radiation treatment.
本研討會全程免費，本活動敬備午餐與茶點，紙本講義與現場座位名額有限，請於10月29日前完成網路報名程序，額滿為止，敬請及早完成報名，當場報名者恕無法提供餐點與講義，請見諒。
11月2日議程
11月4日議程
