据IMS数据，到2015年将有1600亿美元的药品专利过期。2015年的仿制药市场将会迎来新一轮的角逐，中国的医药企业将面临更多的机会和挑战。和中国仿制药市场共同成长的CPhI中国仿制药峰会已经进入了第四年第五届的征程。
CPhI品牌下的第五届中国仿制药峰会2015以“在机遇与挑战中，生产国际化高品质仿制药”为主题。将于2015年3月25-27日在上海世纪皇冠假日酒店举行。届时，来自政府、协会、科研、监管机构、仿制药、生物类似药药企、原料药和材料、设备等供应商企业的150+专家将相聚此次峰会，共同探讨仿制药领域的热点问题。
会议架构：
| 3月25日 | 专题培训A：质量源于设计（QbD）在仿制药申报研发中的应用和案例分析 专题培训B：结合注册审评要求，科学、合理地进行仿制药研发中的杂质研究 |
| 3月26日 | 会议第一天：仿制药审评与合规 |
| 3月27日 | 会议第二天：伴随技术更新的仿制药市场战略分析 |
>> 下载完整会议议程
部分已确认演讲嘉宾：
| 冯毅 | 资深顾问 | 科文顿&柏灵律师事务所（原CFDA-CDE主任助理） |
| 傅鸿鹏博士 | 研究员、药政研究室主任 | 卫生部卫生发展研究中心 |
| 谢沐风 | 副主任药师 | 上海市食品药品检验所 |
| Lesley Zhu | 投资组合副总裁 | 华海美国（曾任职于TEVA和SANDOZ） |
| Dr. Cheryl Li | 仿制药副总裁 | 药明康德 |
| 宋晓东 | 全球注册事务CMC总监 | 强生中国研发 |
| Nicola Travierso | 总经理 | NTC Pharma |
| Deepak Hegde | 产品发展&CMC总监 | GSK |
| 骆世忠 | 总经理 | 北京亚宝国际贸易有限责任公司 |
CPhI第五届中国仿制药峰会2015将集合CPhI全球资源和前四届峰会的精华，为国内外从事仿制药领域的专业人士提供交流与展示的平台，助您提升公司和产品质量，知名度与影响力。
According to IMS data, $1600 million value of generic drugs will be off-patent. There will be a high competitive generic drugs market in 2015, and then pharmaceutical company in China will get more chances and challenges.
The 5th NextGen Conference themed as to manufacture international high quality generics in opportunities and challenges will be held on March 25-27, 2015 in Crowne Plaza Century Park Shanghai. The 5th NextGen Conference organized by CPhI will attract more than 150 experts, who come from government, regulatory, association, research, generics manufactures, CRO&CMO, martial supplier to discuss hot topic in generic drug field.
Conference Structure
March 25
Workshop A:Application and case analysis of Quality by Design (QbD) in generics R&D and manufacture
Workshop B: How to do generics impurity research scientifically and reasonably combing with registration requirement
March 26 Conference Day One: Generics examination and regulation compliance
March 27 Conference Day Two: Market strategy analysis of generics along with the techniques updates
Part of Confirmed Speaker:
Yi Feng Senior Advisor Covington & Burling LLP
(Former CFDA-CDE Director Assistant)
Dr. Hongpeng Fu Department of Pharmaceutical Policy National Health Development&Research Center
Mufeng Xie Associate Chief Pharmacist Shanghai Institutes for Food and Drug Control
Lesley Zhu Corporate Vice President of Portfolio Management Huahai US
(Former TEVA, SANDOZ)
Dr. Cheryl Li. VP, Generics/Consumer Products PDS WuXi Apptec, Inc.
Daniel Song Global CMC RA Director Janssen China R&D
Nicola Travierso General Manager NTC Pharma
Deepak Hegde Product Development (CMC) Director GSK
Shizhong Luo General Manager Beijing Yabao International Trade Co., Ltd
The 5th NextGen Conference will gather all resource of CPhI global and essence of past four conferences to provide you an event about generics regulations, techniques and market strategy.
