同じ製品であっても、欧州と米国では製造販売承認申請の内容や形式が大きく異なる場合があります。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.

講師：Rachel Bombara, Regulatory Services Manager