美國FDA新藥臨床試驗(IND)申請經驗

報名限制與費用:

會員： NT$0

非會員： NT$0

即日起至5/31(二)開放報名，本場次免費報名參加。


主講人：
       何佳樺博士





現職：
Chief Operating Officer, Amarex Taiwan

學歷： 

2010    D.Phil.     Department of Chemistry, Oxford University, UK
2004    B.Sc.       Department of Chemistry, National Tsing Hua University, Taiwan
　　　　　　　　Supplementary subject: Life Science

經歷：

2016 – Present　Chief Operating Officer, Amarex Taiwan, LLC
2016　Assistant Vice President, The Eternity Health Venture Capital & Consulting Company
2015　Senior Manager, Adata Technology Co., LTD.
2013 – 2015　Postdoctoral associate, Helmholtz Zentrum München
2012　Senior scientist, OBI Pharma, INC.
2009 – 2011　Postdoctoral associate, MIT Alliance for Research and Technology, Singapore
2007 – 2009　Laboratory demonstrator, Oxford University
2005　Research assistant, Genomics Research Center of Academia Sinica, Taiwan
2002 – 2004　Research assistant / Internship, National Health Research Institute, Taiwan

專長：

• US FDA/TFDA/NMPA Regulation and Approval Strategies
• Multi-Regional Clinical Trials (MRCTs)
• Good Manufacturing Practices (GMPs)
• Quality System Regulations (QSRs)
• AI Software and Software as Medical Device (SaMD)

著作：

• Human oxygen sensing may have origins in prokaryotic EF-Tuprolyl-hydroxylation; PNAS. 2014, 111(37), 1333-6
• Ribosomal oxygenases are structurally conserved from prokaryotes to humans; Nature. 2014, 510(7505), 422-6
• A multidimensional platform for the purification of non-coding RNA species; Nucleic Acids Res. 2013, 41(17), e168
• Oxygenase Catalysed Ribosome Hydroxylation is Conserved from Prokaryotes to Humans; Nature Chemical Biology, 2012, 8(12), 960-2
• 2’-O Methylation of Intern Adenosine by Flavivirus NS5 Methyltransferase; PLoS Pathogens, 2012, 8(4), 5168-5181
• Identification of N6, N6-Dimethyladenosine in transfer RNA from Mycobacterium Bacille Calmette Guérin; Molecules, 2011, 16(6), 5168-5181
• Inhibition of Hepatitis C Virus Replication by Arsenic Trioxide; AntimicrobAgentsChemother., Aug. 2004, p.2876-2882

演講主題：

美國FDA新藥臨床試驗(IND)申請經驗

內容大綱：

1. Get to Know US FDA
2. Introduction of Investigational New Drug (IND)
3. Pre-IND Consultation Program
4. IND Application Preparation
5. US FDA’s Decision on Your IND

【活動說明】
(一)、會員請至會員專區登入後辦理報名，以維護您的權益。
(二)、本次專題講採用Cisco Webex Meetings。
(三)、本專題演講最後報到時間為16:30，如未於預定時間內報到視同未出席。
(四)、本會於活動結束後一個月內依據「專利師及專利代理人在職進修辦法」登檔造冊2小時予經濟部智慧財產局，惠請參與之專利師及專利代理人於課程活動結束後一個月後至經濟部智慧財產局E網通入口網站登入查詢。
(五)、若臨時不克出席，請於5/31 17:30前，以電郵（mail@twpaa.org.tw）通知本會取消報名。
(六)、活動聯絡人：中華民國專利師公會02-2701-1990分機11 許小姐，mail@twpaa.org.tw。
(七)、本會保留變更活動內容之權利。