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嘉宾信息
发布时间: 2022 - 11 - 24
点击次数: 0
所属职位: 公司首席科学家兼制剂研究院院长
所属公司: 浙江华海药业股份有限公司
个人简介:
郭晓迪博士,现任浙江华海药业股份有限公司首席科学家兼制剂研究院院长。从事药物制剂研发、放大生产、注册申报领域工作的30余年间共计发表论文60余篇,拥有20余项专利,主导开发上市了近百个产品。Dr. Xiaodi GUO is the Chief Scientist and president of Pharmaceutical Research Institute of Zhejiang Huahai Pharmaceutical Co., Ltd. Over the past 30 years, Dr. Guo has published more than 60 articles, owns more than 20 patents and has led the development of nearly 100 products in the field of finished dosage forms development, scale-up production, and application for registration.
发布时间: 2022 - 11 - 24
点击次数: 0
所属职位: 副总裁
所属公司: 四川科伦药业股份有限公司
个人简介:
王亮,现任科伦药业质量副总裁,北京大学国际药物工程硕士,高级工程师。具有27年制药质量管理实战经验,熟悉国内外GMP法规,熟悉注射剂、胶囊剂、片剂等剂型的生产工艺、关键质量属性、关键控制点等。特别是深刻理解注射剂的关键质量控制点及无菌保证要素,曾参与中国医药质量管理协会“湿热灭菌药品参数放行”团体标准起草;参与国家药典委湿热灭菌药品的参数放行、无菌保证指导原则等课题研究;参与中国药品GMP指南无菌药品分册修订工作。Wang Liang, currently the Vice President of Quality of Kelun Pharmaceuticals, Master of International Pharmaceutical Engineering in Peking University, and Senior Engineer, has 27 years of practical experience in pharmaceutical quality management. She is familiar with GMP regulations, both domestic and abroad, and is familiar with the production process, critical quality attributes, and critical control points of injections, capsules, tablets and other dosage forms. In particular, she has a deep understanding of the critical quality control points and sterility assurance elements of injections. She has participated in the drafting of the group standard for 'Parametric Release of Moist Heat Sterilized Drugs' of China Pharmaceutical Quality Management Association; participated in research projects such as the guiding principles for the parametric release and sterility assurance of moist heat sterilized drugs conducted by the State Pharmacopoeia Commission; and participated in the revision of the Sub-volume, Sterile Drug, of Chinese GMP Guidelines for Drugs.
发布时间: 2022 - 11 - 24
点击次数: 0
所属职位: 总经理
所属公司: 山东新华制药股份有限公司
个人简介:
杜德平,男,1969年8月生,山东高密人,汉族,中共党员,研究生学历,高级工程师,执业药师。1987年9月至1991年7月在中国海洋大学学习,1991年7月在山东新华制药股份有限公司参加工作,历任车间产品技术员、技术处主管工程师、车间副主任、车间主任。2008年5至2008年12月,任山东新华制药股份有限公司总经理助理,2008年12月至2010年8月任副总经理,2010年8月至今任总经理。是山东省药学会专业委员会委员、淄博市企业联合会、企业家协会副主席,先后荣获淄博市第六届青年科技奖、振兴淄博五一劳动奖章、淄博市科学技术奖二等奖、2020影响淄博年度创新人物、山东省科学技术奖二等奖、山东省技术市场科技金桥奖、中国石油和化学联合会科技进步奖二等奖等荣誉。山东新华制药股份有限公司1943年诞生于胶东抗日根据地,1948年迁至张店。经过70多年的发展,公司已成为H股、A股上市公司,全球重要的解热镇痛药生产和出口基地,国内重要的心脑血管类、抗感染类、中枢神经类、生物药物等生产企业,拥有化学原料药、医药制剂、医药中间体三大支柱产业,五大产业园区,总资产60亿元,职工6400余名。化学原料药年生产能力4万吨,医药中间体50万吨,片剂80亿片,小容量注射剂8亿支、大容量注射剂1000万瓶、胶囊15亿粒。主导原料药布洛芬、阿司匹林、咖啡因等列模规均居全球前列,拥有吡哌酸等8个国内独家原料药品种。Mr. Du Deping, male, born in August 1969, from Gaomi, Shandong, Han nationality, member of the Communist Party of China,postgraduate qualifications, senior engineer, licensed pharmacist. From September 1987 to July 1991, he studied at Ocean University of China, and worked in Shandong Xinhua Pharmaceutical Co., Ltd. In July 1991. He has served as workshop product technician, technical department supervisor engineer, workshop deputy director, and workshop director. From May 2008 to December 2008, he served as assistant to the general manager of Shandong Xinhua Pharmaceutical Co., Ltd., deputy general manager from December 2008 to August 2010, and general manager since August 2010. Member of the Professional Committee of Shandong Pharmaceutical Association, Vice Chairman of Zibo Enterprise Confederation, Entrepreneur Association, the Sixth Zibo Youth Science and Technology Award, the Revitalization of Zibo “May 1” Labor Medal, the Second Prize of Zibo Science and Technology Award, and the 2020 Impact Innovative Person of the Year in Zibo, the second prize of Shandong Science and Technology Award, the Golden Bridge Award of Shandong Technology Market Science and Technology, the second prize of Science and Technology Progress Award of China Petroleum and Chemical Federation and other honors.Shandong Xinhua Pharmaceutical Co., Ltd. was established in the Jiaodong Anti-Japanese Base in 1943 and moved to Zhangdian in 1948. After more than 70 years of development, she has become a H-share and A-share listed company, and an important global production and export base for antipyretic and analgesics. An important domestic manufacturer of cardiovascular and cerebrovascular, anti-infective, central nervous, and biological drugs. She has three pillar industries: chemical raw materials, pharmaceutical preparations, and pharmaceutical intermediates, five major industrial parks, with total assets of 6 billion RMB, and more than 6,400 employees. The annual production capacity of API is 40,000 tons, 500,000 tons of pharmaceutical intermediates, 8 billion tablets, 800 million small-capacity injections, 10 million bottles of large-capacity injections and 1.5 billion capsules. Leading API such as Ibuprofen, aspirin, and caffeine all rank among the top level in the world, and she has 8 domestic exclu
发布时间: 2022 - 11 - 24
点击次数: 0
所属职位: CTO
所属公司: 年衍药业
个人简介:
李秀艳博士,现任年衍药业CTO, 负责公司的早期研发,CMC,质量及供应链的运营。曾联合创立美国汇智协和(PharmaSynergy),中国药企国际化及跨境合作的战略伙伴。1981至1989年于北京大学化学系学习,1995年获美国康州大学药学博士。曾任职J&J, AMRI, Covidien,方达,药明康德等多家国内国外知名企业。她从一线研发科学家成长为跨界产品创新的领军人,直接领导并参与了多个新药,仿制药,大健康产品, 原料药,辅料,高纯试剂及材料的开发,包括生产工艺开发,分析方法开发,中试生产,及大规模生产的技术转移。在美国强生期间负责产品的全球外包生产和新剂型产品的创新合作,任McNeil OTC业务创新委员会核心成员。外包产品价值2.5亿美元,合作开发产品管线价值10亿美元。参与或领导的项目包括复杂缓控释制剂,透皮给药贴片,软胶囊复杂复方制剂,儿童剂型包括口服液,口崩片,颗粒剂,掩味技术,儿童洗浴护肤品,益生菌保健产品等。得益于与超过200多家的CRDMO,DDS,Biotech and pharma企业的交流访问及合作,积累了丰富的技术评估,外包和供应商尽职调查,合同洽谈的经验。回国后任职药明康德,领导在中国的大健康产品开发和申报的服务,向中国引进先进的健康产品和技术,帮助中国企业国际化。2016年合伙创立汇智协和,业务的重点是帮助中国企业在新形势下以合作多赢的方式尽快建立长期战略合作部局,以领先进入中国市场的特色仿制药及适合中国市场的505b2创新仿制药和创新药为重点,参与了涉及中美欧日台印多方合作的多个JV公司的筹划,尽职调查,合同洽谈。同时帮助华人新药技术公司及国内药企与国外企业开展多层次合作。现兼任世中联经皮给药专业委员会副会长负责国际合作。现为6D孵化的聚焦肾病创新的年衍药业核心成员。Dr. Cheryl Li, currently CTO of Nicoya Therapeutics, formerly CEO and CO-founder of PharmaSynergy, was honored to have served in several reputable CRDMOs, global pharmaceutical companies including Wuxi Apptec, J&J, Covidien, AMRI. She has over 25 years in-depth industry experience with increasing responsibilities in a wide range of professional areas including drug discovery and CMC product development (API and FGs), R&D outsourcing, external manufacturing, product in-licensing and strategic partnership, product due diligence, and business contract negotiations. She had the opportunity to visit and work with more than 200 CRO/CMO and DDS firms globally and is familiar with how thebusinesses are conducted in different parts of the world.She received her Ph.D. degree in Pharmaceutical Sciences from UCONN, MS and BS degrees in Chemistry from Peking University. She has been widely involved in various professional organizations, currently serving as VP of China Transdermal Society. She is aMember of SAPA, ACS and AAPS.
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