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FDA臨床開發情境設定說明:以糖尿病新藥為例
TPP與CDP如何讓臨床研發事半功倍?
TPP與CDP的臨床和商業意義:提問與討論
製作TPP的思維架構
TPP案例分享:提問與討論
(FDA Case Study: Drug Approval – Bringing a New Drug to The Market)
製作CDP的思維架構
CDP案例分享:提問與討論
(FDA Case Study: Drug Approval – Bringing a New Drug to The Market)
如何將TPP與CDP的思維帶入組織的研發決策?
TPP與CDP的實務運用:提問與討論
Q & A
現職:
Vercentrys Biomedical Director Vercentrys Taiwan
Advisory Board, Drug Research Center, NTU
Industry Consultant, Center for Biotechnology, NTU
Translation Consultant, National Palace Museum
Professional Experience:
2021:
— TPP and CDP for new modality drug
— TPP and CDP for novel cell therapy
— TPP for novel anticancer small molecule drug
— TPP for novel antidiabetic small molecule drug
2020:
— TPP and CDP for novel anticancer monoclonal antibody
— TPP and CDP for novel antirheumatic monoclonal antibody
— TPP for novel anticancer small molecule drug
2019:
— TPP and CDP for rheumatoid arthritis biosimilar
— TPP for novel lung cancer imaging technique
Certification:
Certified Medical Publication Professional, International Society for Medical Publication Professionals (ISMPP)
Accredited Chinese-English Translator, Ministry of Education
N1 Japanese Language Proficiency Certificate
Awards:
2020 Gold Award for Patient Education Booklet, Health Promotion Administration of the Ministry of Health and Welfare
2019 Silver Award for Patient Education Booklet, Health Promotion Administration of the Ministry of Health and Welfare