顧曼芹 分享 Quality by Design (QbD)

講題QbD & ICH Q8 Pharmaceutical Development 顧曼芹博士/潤惠生技股份有限公司 總經理  本次演講邀請到實務經驗豐富的顧曼芹博士，講授藥物開發中quality by design的精神與流程、FDA對QbD的要求、以及eCTD查驗登記技術文件介紹，期望對新藥、學名藥及原料藥等從事藥物開發相關同業在工作上有所助益，敬邀各位先進踴躍報名參加！以下是顧博士的演講摘要: Since the publication of ICH Q8 in October 2005 suggesting filing a enhanced product and process understanding in the Pharmaceutical Development Section of the Common Technical Document for regulatory filings, the pharmaceutical industrial has been in flux debating whether to implement Quality by Design (QbD) that has uncertain regulatory benefit but requires intensive effort and upfront investment. With the success of FDA ONDQA pilot program including 9 original NDAs and 2 NDA supplements, FDA has started asking QbD questions whenever meeting with pharmaceutical companies. The pharmaceutical industrial realizes that it is no longer a question whether to implement QbD but when to implement QbD. However, the utilization of QbD principles requires to start at early stages of pharmaceutical development. Therefore, development of a stepwise strategy with delineated procedures accompanying advancement of clinical trial phases is critical to the success of QbD implementation. The objective of the course is to learn the steps necessary to implement QbD from the establishment of target product profile, acquiring prior knowledge, developing formulation and process that is robust, and setting control strategies within the design space in order to obtain regulatory flexibility in the reduction of human bioequivalence and stability testing. In conclusion, a stepwise strategy to gain in-depth formulation and process understanding throughout the clinical trial phases will be discussed. This strategy relies on the development of process analytical technology (PAT) and the utilization of risk analysis (ICH Q9 Quality Risk Management) from the beginning of product development. The implementation of QbD is to bring the pharmaceutical products and the quality system (ICH Q10 Pharmaceutical Quality System) into the 21st century. 主辦單位：小分子藥物產業聯盟/工研院生醫所 時間     ：103年6月20日 (星期五 9:00 am -12:00 noon)  地點    ：集思台大會議中心 達文西廳(台北市羅斯福路四段85號地下一樓)  報名費用：產業聯盟會員免費，外界人士每位1,000元，含講義與餐點。 講師簡歷: 顧曼芹博士 g台大藥學系畢業，Ohio State University藥學系博士g現職為潤惠生技股份有限公司總經理g前職為安成國際藥業股份有限公司總經理和首席技術長,十八個月內有6個具獨創性的ANDA申請,包括3非侵害專利ParagraphIV申請。同時建立6個臨床新藥開發,其中3個為生物藥。g為美國惠氏（現為輝瑞藥廠）之初期藥物研究開發部門主管。主要負責新藥物從開發階段到臨床驗證的研究執行。g共開發超過170個臨床新藥，有85個具獨創性的新化合物新藥之IND 臨床研究申請。成功開發8個上市藥品，包括Suprax，Zosyn/Tazocin，Zebeta，Isovorin，Thioplex，Sonata, Tygacil和Bosutinib 參與製劑研究到新藥上市申請與美國食品藥物管理局之核准前審查程序相關活動。g目前已擁有超過70項專利或發明揭露，並另有62篇論文發表。g為新澤西州製藥討論小組的副主席，並為美國藥學科學家協會之物理藥學及生物藥劑學的接任會長,美國藥典專家委員。g她身為台灣食品藥物管理局和國際藥用輔劑理事會、台大醫學院藥物研究中心專家委員、生技中心經濟部科技專案績效管理專家委員、工研院生醫與醫材研究所專家顧問、生技醫藥國家型科技計畫評估委員、經濟部主導性新產品開發計劃審查委員、國科會生物處產學案審查委員、和各種優質協會的諮詢顧問。