Even if the product is the same, the applications for marketing authorization in Europe and the United States can look very different. 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
