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活動訊息

藥品銜接性試驗評估20周年國際研討會
International Conference on the 20th Anniversary of Bridging Study Evaluation – Ethnic Factors in the Acceptability of Foreign Clinical Data in Global Regulatory Convergence

刊登日期:2022-03-18  |  點閱次數 : 4126 次 
主辦單位: 財團法人醫藥品查驗中心、食品藥物管理署共同主辦
Program Organizer: Center For Drug Evaluation (CDE)
Co-Organizer: TFDA, Chinese Taipei
活動地點: 臺大醫院國際會議中心三樓301廳(台北市中正區徐州路2號)
實體會議、線上直播(擇一參與)
Venue: Participating in-person (at room 301 on NTUH International Convention Center) or virtual(https://youtu.be/qmCeipfNBCU)
活動日期: 111年5月6日(五)09:10~17:00
Date & Time: 09:10~17:00, May 6 (Fri.), 2022

我要報名實體會議 Registration(in person)   我要報名線上直播 Registration(virtually)

 

自2000年12月12日起,參考國際醫藥法規協和會訂定之ICH E5指引,針對新藥查驗登記進行銜接性試驗評估(Bridging Study Evaluation)。過去20年,藉由相關法規與實務操作落實了銜接性試驗評估,進而加速新藥開發、審查及核准。藉由採納銜接性試驗評估提供有效的法規途徑,將國外臨床數據外推至國人族群,並減少非必要且重複性之臨床試驗,同時對製藥業在新藥研發的關鍵時程上,提供法規指引及諮詢輔導。因此,採納ICH E5指引的成功經驗,證明採納與國際標準一致的法規,能與各界進行有效的法規觀點溝通。

 

本會議旨在概述ICH E5指引現況、回顧過去20年政策執行現況,分享法規單位、學界及業界應用的觀點,並邀請PMDA及國際藥廠分享ICH E5在亞洲應用的經驗與考量。為協助各界了解ICH E5的精髓,CDE將於會議中,以案例討論分享法規單位的審查觀點,且進一步說明,藉由跨區域臨床試驗(ICH E17)可有效地取得銜接性試驗資料,可少執行銜接性試驗的負擔。本研討會內容已獲ICH Training Programme認可通過。

 

因應COVID-19疫情,本會議實體與線上併行辦理,歡迎轉知國外業者報名線上參與。實體會場訂於2022年5月6日(五)假臺大醫院國際會議中心三樓301會議廳舉行。實體場次限額250名,線上場次限額1000名,為免向隅,敬請及早報名。本會議全程以英語發音,不提供口譯,亦不收取任何費用。配合防疫,實體參加者請全程配戴口罩。其他防疫措施將配合中央流行疫情指揮中心之防疫政策辦理。

 

Bridging study evaluation (BSE) of new drug applications according to the ICH E5 guideline has been implemented more than 20 years in East Asian region. In past two decades, the implementation of regulation and practical operations of BSE has critically facilitated the process of new drug development, review, and approval by TFDA, Chinese Taipei. The adoption of the BSE requirements apparently resulted in an effective regulatory pathway for extrapolating foreign clinical data to the domestic population and further in the minimization of unnecessary duplicated clinical trials, meanwhile it also provided regulatory guidance and consultation to support the key process of new drug development for pharmaceutical industries.

 

This conference aims to overview the status and execution of the ICH E5 guideline, share perspectives from regulatory, academia and pharma industry. Speakers from PMDA and Norvatis will share their experience and consideration in Asia. To demonstrate the essence of ICH E5, speakers from CDE will share the review consideration through case studies. Furthermore, speakers will illustrate the multiregional clinical trial (MRCT) guided by ICH E17 could help effectively to acquire bridging study data and lessen the burden of executing additional bridging studies. This conference is approved as ICH Recognised Training Programme.

 

Due to the COVID-19 pandemic, the conference will be held both at a physical location and a synchronous online meeting. The physical location will be at Room 301 on NTUH International Convention Center in Taipei on Friday, May 6, 2022. The conference room and online meeting allow 250 and 1000 participants at maximum respectively. Registration is based on first-come-first-served basis. The conference language will be English and no interpretation will be provided. The registration fee is not required. For epidemic prevention, wearing of face masks are required during the conference for those participated in the conference room. Other preventive measures will be taken according to the recommendations by the Central Epidemic Command Center.

 

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