会议介绍 Conference Introduction:

2018 年是生物医药值得纪念的一年。这一年,美国 FDA 创纪录的批准了 23 个生物制品, 2 个细胞治疗产品。大洋彼岸的中国 NMPA(前 CFDA)同样赶在年底之前批准了全国产的两款 PD-1 单抗新药。同时从2017 年的全球畅销药物排行榜 来看,排名前 10 的药物有 8 个是生物制品。所有的这些都表明生物医药已是十年来医药界最火热的领域。另一方面,中国 NMPA 在 2018 年持续的重组与革新,通过制度及政策的变化加速药物审批,鼓励新药研发,提高药物标准,关注药品质量,以保障广大中国人民能够有更多高质量,可负担的医药使用,也预示着生物医药在中国拥有巨大的市场和研发潜力。

美国药典委员会 (USP) 作为全球领先的药物质量标准制定机构, 200 年来我们持续建立有助于确保药品和食品质量、安全性和效用的公共标准及相关方案,以改善全球健康状况。生物制品是 USP 在未来 10年的最重要的关注领域之一。 2018 年的 4 月, USP 首次在中国举办了第一届国际多肽标准与质量论坛,引起了业界广泛的关注。基于 2018 年的成功经验, USP 希望可以继续利用这个平台与全球及中国的业界、监管机构、 供应商开展交流与合作,加强质量意识,共同努力提高中国医药的产品质量,使百姓受益。 2019年, USP 将会扩大论坛讨论的范围,从合成多肽推向整个生物制品,包括重组蛋白、单抗、胰岛素、合成多肽、 细胞治疗及血液制品等。

USP 本次特别邀请海内外科研院校,标准设定机构、法规监管、研发、生产、 CRO/CMO 等专家共聚一堂,将与您共同交流和讨论生物制品中国前景与机遇、 GMP 生产与法规、药品质量研究的技术发展、药典标准更新以及杂质的分析技术和质控标准。

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 23 - 24 in Shanghai/Nanjing, 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.

参会对象 Participants:

重组蛋白、 单抗、胰岛素、 重组/合成多肽、 细胞治疗及血液制品等生物制品领域的原料药/制剂生产、研发人员; 国际注册和法规事务人员; 国际市场开发人员;质量负责人及其专员;质量标准、 法规监管人士;质量和技术研究的学术机构/科研单位人员;以及其他对研讨会主题感兴趣的人员。

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.

演讲嘉宾来自 Speakers:

美国 FDA,美国药典委员会, 国内法规监管机构,国内外科研机构,生物制品研发/生产企业等(详细演讲嘉宾名单和演讲主题将于第二轮通知呈上)
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.