Past Event
日期
March 12-14, 2024
Location
Brussels, Belgium
Dual Filing Strategies: How to Jointly Publish Marketing Applications for EMA and FDA
Rachel Bombara
|Regulatory Services Manager
Even if the product is the same, the applications for marketing authorisation 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.
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