內容概覽 (Overview)

自2013年起，藥物信息協會（DIA）成功舉辦了三屆藥物研發(fā)定量科學論壇，為國內外相關領域的專家、學者、同行提供了一個跨學科的共同探討藥物研發(fā)中和定量科學相關課題的討論平臺。2016年DIA將與中國臨床試驗生物統計學組（CCTS）和中國臨床試驗數據管理學組（CDMC）聯合舉辦第四屆藥物研發(fā)定量科學論壇。近年來，定量決策與法規(guī)科學的長足發(fā)展顯而易見，ICH經歷了重大變革，并且建立了多個工作小組，包括ICHE6（GCP）、E9（統計）、M4E（CTD有效性與效益風險）的修訂以及ICHE17新指南（多區(qū)域臨床試驗）。在中國，CFDA發(fā)布了MRCT新指南和中國臨床試驗生物統計學指導原則。在加強臨床試驗數據自查核查、提高質量的環(huán)境下，本屆論壇以“定量科學與新法規(guī)指南”為主題，詳細解讀新法規(guī)指南，探討為合格和優(yōu)秀的臨床試驗提供科學規(guī)范的統計與完整有效的高質量數據管理等定量科學問題。來自監(jiān)管機構、統計學界以及中國臨床試驗生物統計學組（CCTS）的專家將參與討論，與參會者分享定量科學相關知識和經驗。

Since 2013, DIA China held 3 editions of Quantitative Science Forum, which were successful event series that provided a multi-functional forum within China to discuss quantitative science topics in pharmaceutical product development. The DIA China, China Clinical Trial Statistics (CCTS), and?Clinical Data Management working group of China (CDMC) Working Group will co-host the 4th “DIA China Quantitative Science Forum" in August 2016 again. In the last few years, we have seen significant advance in quantitative decision making and regulatory sciences. Globally, ICH has gone through a significant reform and has established multiple working groups including the revision of the ICH E6 (GCP), E9 (Statistics), M4E (CTD efficacy and benefit-risk), and new guidance ICH E17 (multiple regional clinical trial). In China, CFDA also issued a new guidance on MRCT and a revised draft guidance on statistics principle. Nowadays, the Chinese industry faces greatly severe test on clinical trial data self-inspection and audit. The 2016 forum, with the theme of “Quantitative Sciences and New Regulatory Guidance”, will interpret the new regulatory guidance and share knowledge of quantitative issues in safety, efficacy, risk- benefit, and potentially cost-effective utilization to provide scientific and standardized statistics for the qualified or excellent clinical trials, as well as how to provide complete, effective data with high quality. Dedicated sessions featuring consensus from the key statistics opinion leaders and experts from CCTS will be presented to the participants.

學習內容 (Learning Objectives)

企業(yè) - 會員 | Industry - Member（適用于來自企業(yè)、藥廠和CRO公司的DIA會員注冊） ￥2500

企業(yè) - 非會員 | Industry - Nonmember （適用于來自企業(yè)、藥廠和CRO公司的非會員注冊）￥3500

企業(yè)團體注冊優(yōu)惠 | Group Registration Complementary ￥0

政府 /學術機構 /非盈利機構 - 會員 | Government/NPO - Member ?（適用于來自政府機構的非DIA會員注冊）￥1800

政府 /學術機構 /非盈利機構 - 非會員 | Government/NPO - Nonmember （政府/學術機構/非盈利機構-非會員（含1年會員費））￥2800

學生 - 會員 | Student - Member ￥500

學生 - 非會員 | Student - Nonmember ￥653

講者/主持人 （企業(yè)） | Industry Speaker/Session Chair ￥2300

講者/主持人（學術機構/政府/非盈利機構） | NPO Speaker/Session Chair ￥0