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Dr. Coté孤儿药研讨会
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January 15 - 16, 2018

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2:00pm - 7:00pm

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中国上海浦东新区科苑路1500号

上海张江美居酒店

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Coté Orphan 是一家专注于孤儿药法规事务咨询公司，由前FDA 开发办公室主任Dr.Coté于2012年创立，现为IQVIA旗下子公司。我们长期专注于孤儿药美国和欧洲的法规事务，药物产品风险评估和项目流程管理工作。由前FDA孤儿药开发办公室主任Dr. Timothy Coté 领导的经验丰富的团队能够为您的孤儿药研发流程，从概念提出直至市场开发，提供有效的指导方案。

活动时间

2018年1月15日：1:00PM-5:30PM Dr. Coté 孤儿药研讨会
2018年1月16日：8:00 AM-6:00PM Dr. Coté 1对1指导会议

地点

上海张江美居酒店┃致远厅

会议议程
  • 1:00PM-1:30PM 注册
  • 1:30PM-2:30PM 孤儿药的发展进程
  • 2:30PM-3:00PM 孤儿药研发的商业模式
  • 3:00PM-3:30PM 茶歇
  • 3:30PM-4:30PM FDA孤儿药相关法规事务
  • 4:30PM-5:30PM 招待会
主讲人

Dr. Timothy Coté, MD, MPH
Dr. Coté是孤儿药研发方面的专家，他在美国药监局（FDA）， 美国国立卫生研究院（NIH）以及美国疾控中心（CDC）有23年的工作经验。从2007年到2011年，他担任FDA孤儿药开发办公室（OOPD）主任，在职期间他亲自经办1400+例孤儿药资格认定，其中批准800例。Dr. Coté 退休后于2012年创立了Cote Orphan, 一家专注于孤儿药法规事务的咨询公司，现为IQVIA旗下子公司。

 

 

 

Cote Orphan 专注于孤儿药的服务范围：

  • FDA 孤儿药资格认定（Orphan Drug Designation）
  • EMA 孤儿药资格认定（Orphan Drug Designation）
  • 项目战略评估（Strategic Review）
  • FDA会议（Pre-IND Meeting，Pre-NDA Meeting, ect.）
  • 突破性疗法资格认定 （Breakthrough Designation）
  • 快速审评资格认定（Fast Track Designation）
  • FDA儿童罕见病及热带病优先审评券（Priority Review Voucher ）
  • IND申报
  • NDA申报, ANDA申报，BLA申报，MAA申报

Coté Orphan 在美国和欧洲孤儿药市场的长期服务经验使其成为全球范围内孤儿药法规事务方面最好的合作伙伴。Coté Orphan 提供的独一无二的服务将为您的孤儿药研发项目提供高效率，高质量，定制化的解决方案。

中国市场业务拓展请联系
张雅林| Yalin Zhang
Email: Yalin.Zhang@IQVIA.com
微信：Coteorphan_Yalin

ophan drug workshop

协办单位：

中国医药保健品进出口商会
ophan drug workshop

Abpro
ophan drug workshop
 
徐军MD,MBA,MS, 战略联盟高级副总裁
手机：+1 732.822.1963
             +86 135.2289.2028
邮箱：jxu@abrpo-labs.com

 

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