即便产品相同，欧洲与美国上市许可申请材料仍存在显著差异。This presentation will explore the major differences between EMA marketing applications (MAAs) and U.S. FDA marketing applications (NDAs/BLAs), strategies for publishing in tandem, and even means to “clone” sections for efficiency. Tips for proactive planning, eCTD publishing, hyperlink creation, and more will be shared throughout.

Presenter: Rachel Bombara, Regulatory Services Manager