【QA系列】維持高品質QA:實務進階主題研討 (2019年度 第2期)

2019/10/26 (09:30~16:30) 開放早鳥預約
本次主題: 從化學藥到生技製藥 台灣製藥產業70年

【線上報名】線上報名及預約
 上課日期/時間 2019/10/26  (週六 09:30~16:30)
【課程規劃專家及講師】史又南博士 / 台灣浩鼎生技副總經理
【適合對象】生技製藥廠品保相關人員、QA系列課程舊生、GMP探討有興趣者。
【課程介紹&架構】
In this lecture, we are going to review  the trends, the hot and emerging topics which significantly impact the pharma and healthcare industry  and to learn from the history of both Taiwan and global industry . It is expected that by doing so,  we are able to have a better view of where we are NOW, what we may encounter in the next 10, 20 years and how we prepare to react to the wave of changes.

觀點1:化學藥到生技製藥 台灣製藥產業70
- Taiwan's pharma industry.
- Chemical, biological, new drug
- Impacts on Taiwan's pharma industry

觀點2: NEXT 70 years 生技製藥產業
- Trends of the pharma, healthcare industry
- What's coming?
- Are you ready for these?
【上課講義】 講師自編教材(PPT)
【參考教材】學員可自行參閱或代購
台灣製藥工業發展70年光影》
 (出版單位:TPMA台灣製藥工業同業公會) 售價: 1,000/發行日:2018/4/1

研討內容暨授課大綱】
說明:實務研討相關主題及參考資料或文獻,歡迎您於上課前先行參閱,以利參與課堂討論及分享!時數配當以講師規劃及參考課前調查結果適度安排或調整

How would new FDA regulations affect the assessment of drug approval, and the distribution of drugs?
  ♦GDUFA
  ♦New Knowledge-aided Assessment & Structured Application (KASA)system
  ♦The Mutual Recognition Agreement (MRA) between FDA and European Union
  ♦Drug Supply Chain Security Act (DSCSA)

The importance and the trends of data analysis and integrity
  ♦Data integrity
       •Novartis CEO (sort of) admits mishandling Zolgensma crisis
       •Does Novartis' delay in probing data manipulation claims spell trouble?
       •Data Integrity Survey Results
       •What Your Organizational Design Says About Your Commitment To Data Integrity
       •A Brave New World of Data Integrity
       •食品藥物研究年報Ann. Rept. Food Drug Res. 9, 379 – 388, 2018
       •國內藥廠數據完整性專案查核結果研析
  ♦Data analysis
       •Root cause analysis
       •RIP Spreadsheets and Fishbones

Things that we should know about drug manufacturing & supply chain management
   ♦R&D / GMP?
    understand the “Regulatory Expectation” is something YOU need to know. You are NOT just         
    R&D, MUST think about eventual commercialization → GMP!!
    GLP; GCP; GDP; GxP → GMP
   ♦BioPharma Maintenance 4.0: the next revolution in Bio/Pharma manufacturing
   ♦Preparing For A Transition From Batch To Continuous Processing
   ♦Does A Phase 1 Virtual Biopharma Company Need A cGMP Quality System?
   ♦Serialization, the Next step

Emerging Industry that we should keep our eyes on
   ♦Current status of Taiwan’s pharma industry: TAIWAN’s Pharma firms, exclude medical device
   ♦Stem cell therapy
   ♦Longevity Industry
   ♦AI in pharma and healthcare industry
      •Highlights in AI for Drug Discovery Q2 2019,
      •How AI is Democratizing Access to Enhanced Healthcare in the Pacific
      •A New Framework to Address Increasing Complexity in AI & DeepTech
      •Deep Knowledge Analytics (DKA) Pharma Division
      •AI for Drug Discovery 2019: Intelligence, Analysis, Forecasts
      •DeepTech news briefs 

References
    ♦Fierce
    ♦BioProcess Online
    ♦USP
    ♦FDA on Warning Letter
    ♦GOV.UK
    ♦Pharmaceutical Online Newsletter
    ♦ISPE
    ♦PDA
    ♦IPQ, International Pharmaceutical Quality, News Alert
    ♦LinkedIn
    ♦ECA Academy, GMP News
    ♦ACS, American Chemical Society
Be prepared for the future, OPEN-minded, adapt NEW development.

【上課時間】2019/10/26,週六9:30-12:30 / 13:30-16:30
【課程時數】6小時
【上課地點】台北市大安區和平東路二段106號4樓(科技大樓) 
【課程費用】
  • 非本會團體會員NT$4,800,本協會團體會員價NT$4,200
  • 10/15 前完成報名及繳費者可享優惠價 NT$ 4,000 (限額)
  • 2人以上同時報名,可享優惠價NT$ 4,000 
  • QA舊生回訓,可享優惠價NT$ 3,600
【線上報名】線上報名及預約
【諮詢專線】02-77003883 分機11或 分機12 歡迎來電
  • (以上課程大綱及開課日期及授課師資等; 本協會保有異動權,如有變動將會提前通知)