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EMEA Thought Leadership
Developing IQVIA’s positions on key trends in the pharma and life sciences industries, with a focus on EMEA.
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EMEA Thought Leadership
Developing IQVIA’s positions on key trends in the pharma and life sciences industries, with a focus on EMEA.
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EMEA Thought Leadership
Developing IQVIA’s positions on key trends in the pharma and life sciences industries, with a focus on EMEA.
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Middle East & Africa
EMEA Thought Leadership
Developing IQVIA’s positions on key trends in the pharma and life sciences industries, with a focus on EMEA.
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Impacting People's Lives
"We strive to help improve outcomes and create a healthier, more sustainable world for people everywhere.
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Harness the power to transform clinical development
Reimagine clinical development by intelligently connecting data, technology, and analytics to optimize your trials. The result? Faster decision making and reduced risk so you can deliver life-changing therapies faster.
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Real World Evidence. Real Confidence. Real Results.
Generate and disseminate evidence that answers crucial clinical, regulatory and commercial questions, enabling you to drive smarter decisions and meet your stakeholder needs with confidence.
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See markets more clearly. Opportunities more often.
Elevate commercial models with precision and speed using AI-driven analytics and technology that illuminate hidden insights in data.
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Service driven. Tech-enabled. Integrated compliance.
Orchestrate your success across the complete compliance lifecycle with best-in-class services and solutions for safety, regulatory, quality and medical information.
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Intelligence that transforms life sciences end-to-end.
When your destination is a healthier world, making intelligent connections between data, technology, and services is your roadmap.
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Explore our library of insights, thought leadership, and the latest topics & trends in healthcare.
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An in-depth exploration of the global healthcare ecosystem with timely research, insightful analysis, and scientific expertise.
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Human Data Science Cloud
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IQVIA Innovation Hub
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Patient Experience powered by Apple
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IQVIA AI is Healthcare-grade AI
Building on a rich history of developing AI for healthcare, IQVIA AI connects the right data, technology, and expertise to address the unique needs of healthcare. It's what we call Healthcare-grade AI.
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Your healthcare data deserves more than just a cloud.
The IQVIA Human Data Science Cloud is our unique capability designed to enable healthcare-grade analytics, tools, and data management solutions to deliver fit-for-purpose global data at scale.
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Innovations make an impact when bold ideas meet powerful partnerships
The IQVIA Innovation Hub connects start-ups with the extensive IQVIA network of assets, resources, clients, and partners. Together, we can help lead the future of healthcare with the extensive IQVIA network of assets, resources, clients, and partners.
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Proven, faster DCT solutions
IQVIA Decentralized Trials deliver purpose-built clinical services and technologies that engage the right patients wherever they are. Our hybrid and fully virtual solutions have been used more than any others.
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IQVIA Patient Experience Solutions powered by Apple
Empowering patients to personalize their healthcare and connecting them to caregivers has the potential to change the care delivery paradigm. IQVIA and Apple are collaborating to bring this exciting future of personalized care directly to devices patients already have and use.
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Our mission is to accelerate innovation for a healthier world. Together, we can solve customer challenges and improve patient lives.
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Careers, culture and everything in between. Find out what’s going on right here, right now.
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WE’RE HIRING
"Improving human health requires brave thinkers who are willing to explore new ideas and build on successes. Unleash your potential with us.
SEARCH JOBSCoté 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
协办单位：
中国医药保健品进出口商会
Abpro
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