News Express: UM doctoral students present their study at RAPS Convergence
新聞快訊：澳大博士生研究於國際權威RAPS年會展示
學生研究展示
The poster display of the UM students
澳大藥品監管科學研究於國際權威RAPS年會展示
澳門大學中華醫藥研究院博士生時君楠和陳獻文的研究有助完善現代化藥品監管體系，入選美國醫療法規事務學會（Regulatory Affairs Professionals Society, RAPS）會議，並獲邀於美國2024年全球監管事務年度大會（RAPS Convergence）展示研究成果。
今年大會收到來自全球各地的研究論文，經過專家學者嚴格審核後，最終選出四項研究在年會進行海報展示，其中包括時君楠和陳獻文的論文《通過基準評估提升藥品註冊與上市批准的監管能力建設》（Benchmarking drug regulatory systems for capacity building in registration and marketing authorization）。他們通過基準評估對藥品註冊與上市批准的監管能力，進行系統的分析並提出監管能力構建的建議，藉此助力現代化藥品監管體系的完善。該研究的導師為澳大中華醫藥研究院助理教授、藥品監管科學研究中心副主任吳靄琳和澳大中華醫藥研究院教授胡豪。
此外，時君楠還被RAPS選為是次會議的學生大使之一，承擔會議協調及管理工作。她表示，是次獲邀於國際權威的監管會議展示成果，並深度參與會議的組織和執行，過程中接觸到頂尖的專家、與同道互相學習和交流，既拓寬了個人視野，也對其專業發展意義重大。
RAPS是當今全球最具規模和聲望的監管專業組織，專注於醫療器械、生物製藥及體外診斷（IVD）等領域的監管事務。其所舉辦之年會，匯集監管機構、行業、學術界和臨床組織的頂尖代表，提供監管事務領域最前沿的知識分享與交流平台。2024年全球大會匯聚了世界各地超過2,000名藥品監管事務的官員、專家及學者，共同探討全球監管趨勢與合作機會。
澳大藥品監管科研究中心於2023年組建，團隊此前已發表諸多不同方向的監管科學研究成果。研究院配合澳門“1+4”經濟適度多元展策略，貫徹“守正創新”的理念，持續推進監管科學相關領域的研究，以推動中醫藥規範化、國際化和現代化為己任，致力傳承創新中醫藥研究，開發高質量研究成果，培養更多優秀中醫藥複合型人才，為“一國兩制”事業行穩致遠作出貢獻。
欲瀏覽官網版可登入以下連結:
https://www.um.edu.mo/zh-hant/news-and-press-releases/presss-release/detail/59210/
UM’s drug regulatory science research presented at RAPS Convergence
A study by Shi Junnan and Chen Xianwen, doctoral students in the Institute of Chinese Medical Sciences (ICMS) at the University of Macau (UM), was accepted by the Regulatory Affairs Professionals Society (RAPS). They were invited to present their research at the RAPS Convergence 2024 in the US. The study contributes to the enhancement of modern drug regulatory systems.
This year’s RAPS Convergence received research papers from around the world. After rigorous review by experts and scholars, four studies were selected for the Student Capstone Poster Display, including ‘Benchmarking drug regulatory systems for capacity building in registration and marketing authorization’ by Shi and Chen. They carried out a systematic analysis of regulatory capacity in drug registration and marketing authorisation through benchmarking and made suggestions on regulatory capacity building, with the aim of enhancing modern drug regulatory systems. The study was supervised by Ung Oi Lam, assistant professor in ICMS and deputy director of the Centre for Pharmaceutical Regulatory Sciences, UM; and Hu Hao, professor in ICMS. In addition, Shi served as a student ambassador for the RAPS Convergence and assisted in event coordination and management.
To read the news on UM’s official website, please visit the following link:
https://www.um.edu.mo/news-and-press-releases/presss-release/detail/59210/