Greetings!
Getting a new drug to market requires more than promising science. It requires navigating a complex regulatory pathway from development through submission and approval. This introductory workshop breaks down the fundamentals of Regulatory Affairs and the New Drug Submission (NDS) process, including how to:
- Understand the drug development and approval pathway
- Navigate the key components of a New Drug Submission
- Understand notice types, priority review, and pre-submission meetings
- Structure submissions using the Common Technical Document (CTD)
- Understand submission formatting, filing, screening, and the advantages of eCTD
Whether you're entering Regulatory Affairs or looking to strengthen your foundational knowledge, this session provides a practical overview of how drug submissions move through the regulatory process.
Early Bird Offer: Register by August 14 and use code SAVE20 to receive 20% off your registration.
*All participants will receive a Certificate of Attendance upon completion. |
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