【學員對象】
- 從事藥品化學製程管制(CMC)工作者
- 目前從事臨床試驗相關工作者(如PI,PM,RA,RD,MW,MA,SM,ST,CRA,CRC,QC,QA等…)
- 目前從事新藥臨床試驗相關工作者(如PI,PM,RA,RD,MW,MA,SM,ST,CRA,CRC,QC,QA等…)
【授課大綱】
1. ICH品質法規指引中有關生物藥品之重點介紹
Pinpoint ICH Quality Guidelines Focused on Biologics
1.1 生物藥臨床一期到三期及上市申請的CMC資料要求
Phase-appropriate Biologics CMC Development: From Clinical Phase 1 to 3 and Market Authorization Application (BLA)
1.2 法規單位在每個產品開發時期的期望及要求比較
Compare the expectations and requirements by regulatory authority at different phases of product development
2. 生物藥品CTD模組三之撰寫技巧
2.1國際通用技術文件CTD架構
Structure of Common technical document
2.2 生物藥品CTD模組三(CMC)的細項資訊
Content information of a module 3 (CMC) package for a biological drug
2.3 小分子與生物藥品CTD 模組三主要差異比較
The significant differences in module 3 of a biological drug compared to a small molecule drug
2.4 從早期研發到取得BLA 351(k) Biosimilar Application經驗分享
Experience from early stage of research and development to receiving BLA 351(k) Biosimilar Application
3. 針對生物藥與主管機關諮詢會議BLA Regulatory Consultation Meetings with FDA
3.1 法規諮詢會議經驗分享
Experience of attending BLA 351(k) regulatory consultation meetings
3.2 如何準備諮詢會議資料
How to draft a briefing package: contents, questions, and the company’s positions
【師資介紹】
梁詩婕
現職：台灣光鹽生物科技學苑 法規顧問
