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Program |
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Date： |
3rd-4th May, 2016 |
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Venue： |
NTUH International Convention Center (台大醫院國際會議中心) |
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No.2, Xuzhou Rd., Zhongzheng Dist., Taipei City 100, Taiwan (100台北市中正區徐州路2號) |
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Date： |
May 3, 2016 (Tuesday) |
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Venue： |
Room 301, NTUH International Convention Center |
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Time |
Topics |
Speakers |
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8:30~9:00 |
Registration |
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Day-to-Day Operations for Drug Development |
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9:00~9:10 |
Opening Remarks |
莊裕澤 主任
國研院科技政策研究與資訊中心
Dr. Yuh-Jzer Joung
Director General, Science & Technology Policy Research and Information Center
(STPI), National Applied Research
Laboratories (NARLabs)
張鴻仁副理事長
台灣研發型生技新藥發展協會
Hong-Jen Chang, M.D., M.P.H.
Vice Chairman, TRPMA
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9:10~10:10 |
Session 1 : Project Manager’s view of Drug Development – Building a generic/universal drug development plan (a check list) for new drug development (small/biologics)
1. Project/Program Team assembly / management
2. Project Plan building based on development milestones
a. Lead Declaration (for current chemical series)
b. Commit to Lead Optimization to Candidate Selection
c. Candidate Selection to IND Submission /First time in human (FTIH) Approval
d. Commit to FTIH to Proof of Concept (POC) / End of Phase 2 (EOP2) Meeting /Commit to Product Development
e. PoC to Commit to Phase III
f. Commit to Phase III to Global Market Application
Preparation/Submission (regulatory)
g. Submit BLA/NDA/MAA/J-NDA to Market Launch |
Lei Chuang |
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10:10-10:25 |
Q&A |
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10:25-10:45 |
Coffee break |
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10:45-11:45 |
Session 2 : Product Development Process
1. Product Development Process Trend – ICH Q8 and Q11
2. CMC Product and Process Developmental hurdles –building a product and process development roadmap to turn potential road block into opportunity
3. CMC Regulatory Compliance - manufacturing facility and analytical testing laboratory to ensure cGMP compliance in day-to-day operation |
Frank Lee |
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11:45-12:00 |
Q&A |
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Afternoon Round-table Session – Hand-on exercises with case-studies |
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Time |
Topics |
14:00-15:20
Part A
15:20-15:40
Switch Room
15:40-17:00
Part B |
Track 1 |
Track 2 |
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Venue: Room 202, NTUH International Convention Center |
Venue: Room 402A, NTUH International Convention Center |
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Speaker: Lei Chuang |
Speaker: Frank Lee |
1. Assembly your Project Development
Team
2. How to use your competitor’s
Package Insert/your TPP to build a
development plan
3. Now you have a plan – how to use it? |
1. How to design and manage a
Product Development Plan?
2. If you have an in-house
manufacturing facility and analytical
testing labs, how to operate under
cGMP compliance?
3. If you use a CMO for manufacturing
and/or CRO for analytical testing,
how to select and assure they are
under cGMP compliance? |
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Date： |
May 4, 2016 (Wednesday) |
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Venue： |
Room 301, NTUH International Convention Center |
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Time |
Topics |
Speakers |
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8:30~9:00 |
Registration |
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Preparation of FDA Submissions and Regulatory Compliance (INDs, NDAs, BLAs, ANDAs, biosimilar, post-approval supplements) |
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09:00-10:00 |
Session 3: FDA submission process and practice (i.e., INDs, NDAs, BLAs, ANDAs)
1. An overview of global regulatory process for new drug
development
2. Communication with Agency - FDA meetings
3. ICH 21 CFR 312- IND submission
4. eCTD preparation
5. BLA/NDA Submission/Review/Approval process (PDUFA V)
6. ANDA submission |
Lei Chuang |
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10:00-10:15 |
Q&A |
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10:15-10:35 |
Coffee break |
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10:35-11:35 |
Session 4 : CMC regulatory preparation
1. CMC dossier preparation for IND/BLA/NDA
2. CMC dossier preparation for EMA
3. CMC dossier preparation for other areas (e.g., JNDA) |
Frank Lee |
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11:35-11:50 |
Q&A |
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Afternoon Round-table Session – Hand-on Exercises with case-studies |
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Time |
Topics |
14:00-15:20
Part A
15:20-15:40
Switch Room
15:40-17:00
Part B |
Track 1 |
Track 2 |
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Venue: Room 202, NTUH International Convention Center |
Venue: Room 203, NTUH International Convention Center |
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Speaker: Lei Chuang |
Speaker: Frank Lee |
1. Prepare a submission plan
2. Calculate your review time |
1. Regulatory writing for CMC vs.
Technical Writing
2. Hand-on eCTD Module Writings with
examples – DS, DP, and/or Analytical |
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