Greetings!
A successful New Drug Submission is not simply a collection of scientific data. It is a structured regulatory case for a product, and understanding how that case is assembled, reviewed, and communicated is essential to navigating the approval process.
This workshop takes a closer look at the mechanics behind New Drug Submissions, including how to:
- Understand the essential requirements and components of an NDS
- Recognize different notice types and how they fit within the approval process
- Understand priority review policies and the role of pre-submission meetings
- Navigate the structure and purpose of the Common Technical Document (CTD) modules
- Understand submission formatting, filing, screening, and the advantages of eCTD
For professionals working in Regulatory Affairs, drug development, quality assurance, or pharmaceutical submissions, this session provides practical insight into how regulatory information is structured and moved through the submission and review process.
*All participants will receive a Certificate of Attendance upon completion. |
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