FDA新药注册审批全解读

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作者 - Kristi Miller博士,普米尔医药法规事务部全球负责人 主讲人 - 裴明,普米尔医药大中华区商务发展负责人

About this talk

新药研发一直是生物医药界最引人关注的领域。随着法规环境日趋完善,中国医药产业逐渐与全球体系接轨,医药研发市场愈发火热,生物医疗企业的国际化之路越走越宽。普米尔医药大中华区商务发展负责人裴明将为大家深度解读有关FDA新药注册审批的相关法规事务,包括FDA新药临床试验如何申报、申报资料及药品生产质量管理规范详解、如何采用境外数据进行FDA的新药临床试验申请等。

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