內(nèi)容概覽 (Overview)

自2013年起，藥物信息協(xié)會(huì)（DIA）成功舉辦了三屆藥物研發(fā)定量科學(xué)論壇，為國(guó)內(nèi)外相關(guān)領(lǐng)域的專家、學(xué)者、同行提供了一個(gè)跨學(xué)科的共同探討藥物研發(fā)中和定量科學(xué)相關(guān)課題的討論平臺(tái)。2016年DIA將與中國(guó)臨床試驗(yàn)生物統(tǒng)計(jì)學(xué)組（CCTS）和中國(guó)臨床試驗(yàn)數(shù)據(jù)管理學(xué)組（CDMC）聯(lián)合舉辦第四屆藥物研發(fā)定量科學(xué)論壇。近年來，定量決策與法規(guī)科學(xué)的長(zhǎng)足發(fā)展顯而易見，ICH經(jīng)歷了重大變革，并且建立了多個(gè)工作小組，包括ICHE6（GCP）、E9（統(tǒng)計(jì)）、M4E（CTD有效性與效益風(fēng)險(xiǎn)）的修訂以及ICHE17新指南（多區(qū)域臨床試驗(yàn)）。在中國(guó)，CFDA發(fā)布了MRCT新指南和中國(guó)臨床試驗(yàn)生物統(tǒng)計(jì)學(xué)指導(dǎo)原則。在加強(qiáng)臨床試驗(yàn)數(shù)據(jù)自查核查、提高質(zhì)量的環(huán)境下，本屆論壇以“定量科學(xué)與新法規(guī)指南”為主題，詳細(xì)解讀新法規(guī)指南，探討為合格和優(yōu)秀的臨床試驗(yàn)提供科學(xué)規(guī)范的統(tǒng)計(jì)與完整有效的高質(zhì)量數(shù)據(jù)管理等定量科學(xué)問題。來自監(jiān)管機(jī)構(gòu)、統(tǒng)計(jì)學(xué)界以及中國(guó)臨床試驗(yàn)生物統(tǒng)計(jì)學(xué)組（CCTS）的專家將參與討論，與參會(huì)者分享定量科學(xué)相關(guān)知識(shí)和經(jīng)驗(yàn)。

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 In China, CFDA also issued a new guidance on MRCT and a revised draft guidance on statistics principle.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(xué)習(xí)內(nèi)容 (Learning Objectives)

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

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

企業(yè)團(tuán)體注冊(cè)優(yōu)惠 | Group Registration Complementary ￥0

政府 /學(xué)術(shù)機(jī)構(gòu) /非盈利機(jī)構(gòu) - 會(huì)員 | Government/NPO - Member ?（適用于來自政府機(jī)構(gòu)的非DIA會(huì)員注冊(cè)）￥1800

政府 /學(xué)術(shù)機(jī)構(gòu) /非盈利機(jī)構(gòu) - 非會(huì)員 | Government/NPO - Nonmember （政府/學(xué)術(shù)機(jī)構(gòu)/非盈利機(jī)構(gòu)-非會(huì)員（含1年會(huì)員費(fèi)））￥2800

學(xué)生 - 會(huì)員 | Student - Member ￥500

學(xué)生 - 非會(huì)員 | Student - Nonmember ￥653

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

講者/主持人（學(xué)術(shù)機(jī)構(gòu)/政府/非盈利機(jī)構(gòu)） | NPO Speaker/Session Chair ￥0