會議介紹 Conference Introduction：
2018 年是生物醫(yī)藥值得紀(jì)念的一年。這一年，美國 FDA 創(chuàng)紀(jì)錄的批準(zhǔn)了 23 個生物制品， 2 個細(xì)胞治療產(chǎn)品。大洋彼岸的中國 NMPA（前 CFDA）同樣趕在年底之前批準(zhǔn)了全國產(chǎn)的兩款 PD-1 單抗新藥。同時從2017 年的全球暢銷藥物排行榜 來看，排名前 10 的藥物有 8 個是生物制品。所有的這些都表明生物醫(yī)藥已是十年來醫(yī)藥界最火熱的領(lǐng)域。另一方面，中國 NMPA 在 2018 年持續(xù)的重組與革新，通過制度及政策的變化加速藥物審批，鼓勵新藥研發(fā)，提高藥物標(biāo)準(zhǔn)，關(guān)注藥品質(zhì)量，以保障廣大中國人民能夠有更多高質(zhì)量，可負(fù)擔(dān)的醫(yī)藥使用，也預(yù)示著生物醫(yī)藥在中國擁有巨大的市場和研發(fā)潛力。
美國藥典委員會 (USP) 作為全球領(lǐng)先的藥物質(zhì)量標(biāo)準(zhǔn)制定機構(gòu)， 200 年來我們持續(xù)建立有助于確保藥品和食品質(zhì)量、安全性和效用的公共標(biāo)準(zhǔn)及相關(guān)方案，以改善全球健康狀況。生物制品是 USP 在未來 10年的最重要的關(guān)注領(lǐng)域之一。 2018 年的 4 月， USP 首次在中國舉辦了第一屆國際多肽標(biāo)準(zhǔn)與質(zhì)量論壇，引起了業(yè)界廣泛的關(guān)注?；?2018 年的成功經(jīng)驗， USP 希望可以繼續(xù)利用這個平臺與全球及中國的業(yè)界、監(jiān)管機構(gòu)、 供應(yīng)商開展交流與合作，加強質(zhì)量意識，共同努力提高中國醫(yī)藥的產(chǎn)品質(zhì)量，使百姓受益。 2019年， USP 將會擴大論壇討論的范圍，從合成多肽推向整個生物制品，包括重組蛋白、單抗、胰島素、合成多肽、 細(xì)胞治療及血液制品等。
USP 本次特別邀請海內(nèi)外科研院校，標(biāo)準(zhǔn)設(shè)定機構(gòu)、法規(guī)監(jiān)管、研發(fā)、生產(chǎn)、 CRO/CMO 等專家共聚一堂，將與您共同交流和討論生物制品中國前景與機遇、 GMP 生產(chǎn)與法規(guī)、藥品質(zhì)量研究的技術(shù)發(fā)展、藥典標(biāo)準(zhǔn)更新以及雜質(zhì)的分析技術(shù)和質(zhì)控標(biāo)準(zhǔn)。
Biologics achieved remarkable success in 2018. US FDA approved 23 biologics and 2 cell therapy drugs while China NMPA (former CFDA) also approved 2 domestic PD-1 monoclonal antibodies by the end of the year. In 2017, among the world’s top 10 best-selling drugs, 8 came from biologics. China NMPA also continuously reforms its organization and policy to accelerate the drug approval process and encourages innovation while ensuring high quality and affordable drugs to the huge Chinese population.
USP is the global leading standard-setting organization for medicines. For almost 200 years, we continuously improve global health through public standards and related programs that help ensure the quality, safety, and benefit of medicines. Biologics is one of the most important areas for investment in USP for the next 10 years. In April 2018, USP organized the inaugural International Therapeutic Peptides Forum in China. With the great success of the workshop, USP decides to continue utilizing such platform to collaborate with global and local industries, regulatory agencies, suppliers and other key stakeholders to improve the quality and standards in
biologics to benefit more people in China. In 2019, USP will expand topics at the Forum from therapeutic peptides to all biologics, including recombinant proteins, monoclonal antibodies, insulins, synthetic peptides, cell therapy and blood products, etc.
USP China invites experts, both domestic and overseas, from academic institutions, regulatory agencies, manufacturing industry, research and development, CRO/CDMO, and other standard-setting organizations, to participate and gather for the USP International Biologics Forum on Quality and Standards 2019, planned for
May 22 - 24 in Shanghai, China. The forum will provide the platform for conference attendees to present and discuss perspectives on current landscapes and future opportunities of biologics drugs in China, GMP manufacturing and regulations, state-of-the-art technologies for biologics quality, updates on biologics standards, and analytical technologies and quality standards for impurities.
參會對象 Participants：
重組蛋白、 單抗、胰島素、 重組/合成多肽、 細(xì)胞治療及血液制品等生物制品領(lǐng)域的原料藥/制劑生產(chǎn)、研發(fā)人員； 國際注冊和法規(guī)事務(wù)人員； 國際市場開發(fā)人員；質(zhì)量負(fù)責(zé)人及其專員；質(zhì)量標(biāo)準(zhǔn)、 法規(guī)監(jiān)管人士；質(zhì)量和技術(shù)研究的學(xué)術(shù)機構(gòu)/科研單位人員；以及其他對研討會主題感興趣的人員。
Biologics (recombinant proteins, monoclonal antibodies, insulins, synthetic peptides, cell therapy, blood products, etc.) API/formulation manufacturing and R&D; international registration and regulatory affairs; international marketing; quality control and quality assurance; standard-setting and regulatory; academic research involving quality and analytical technologies; others interested in the topics of the international forum.
演講嘉賓來自 Speakers：
美國 FDA，美國藥典委員會， 國內(nèi)法規(guī)監(jiān)管機構(gòu)，國內(nèi)外科研機構(gòu)，生物制品研發(fā)/生產(chǎn)企業(yè)等（詳細(xì)演講嘉賓名單和演講主題將于第二輪通知呈上）
Experts come from US FDA, USP, China Regulatory Authority, Industry / Institutions / Associations. Detailed speaker list and presentation topics will be available in the next round announcement.