重磅!精鼎医药成立法规和市场准入咨询服务专业团队,帮助客户更高效地向患者提供创新疗法

2020-01-16 MedSci MedSci

2020年1月16日,精鼎医药,一家领先的、致力于加速创新疗法研发和上市以改善人类健康的解决方案的临床试验机构(涵盖从临床开发到商业化的各个阶段)近日宣布:该公司已将其内部法规和市场准入团队资源进行整合并成立了一支提供法规与市场准入咨询服务的专业团队,旨在尽早开始帮助客户实现药物临床开发的优化。精鼎医药新组建的法规与市场准入团队在全球范围内拥有1000多名提供咨询服务的全职员工,其中包括约100名

2020年1月16日,精鼎医药,一家领先的、致力于加速创新疗法研发和上市以改善人类健康的解决方案的临床试验机构(涵盖从临床开发到商业化的各个阶段)近日宣布:该公司已将其内部法规和市场准入团队资源进行整合并成立了一支提供法规与市场准入咨询服务的专业团队,旨在尽早开始帮助客户实现药物临床开发的优化。精鼎医药新组建的法规与市场准入团队在全球范围内拥有1000多名提供咨询服务的全职员工,其中包括约100名之前在监管部门工作过的监管者和从事卫生技术评估(HTA)的人员。他们拥有丰富的专业知识,并谙熟公司在将新疗法交付给患者的过程中所需要遵守的所有相关法规、指南以及如何与利益相关方进行沟通合作。
 
精鼎医药法规与市场准入部门高级副总裁Paul Bridges表示:“如今,获得监管机构颁布的上市许可只是将新疗法推向市场的第一步。如果能将监管机构、医保支付方和患者的不同需求进行整体考虑,并确保这些需求在临床开发策略中能得到很好地体现,药企可以更加优化其临床开发计划,推动更智能、更有效和以患者为中心的开发策略的实施,以提升药品开发的速度和患者对创新药品的可及性。”
 
精鼎医药成立的法规与市场准入咨询服务组织汇集了曾在全球主要药品和器械监管机构(包括美国的FDA、英国的MHRA和中国的NMPA)任职的监管者、具有深厚技术专长的临床治疗专家、具有HTA成功经验的市场准入专家以及擅长通过学术沟通加强与利益相关方合作的医疗交流专家。通过全方位能力的整合,精鼎医药旨在帮助客户节省整个药物开发过程所需的时间和资源。
 
精鼎医药执行副总裁兼首席商业和战略官Peyton Howell补充说道:“我们深知每一个药物开发计划的目标都是为了给有需求的患者带来实际的获益。本着以患者为中心的理念,我们成立了这支专注于药品法规与市场准入咨询的专业团队,以帮助药企克服产品法规和市场准入的障碍,避免开发过程中出现不必要的延迟,从而缩短创新药上市的时间。”

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    2020-01-18 cathymary
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    2020-01-18 xxxx1054
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    2020-01-18 kcb074
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    2020-01-17 txqjm

    谢谢了学习了

    0

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