Greetings!
A promising drug doesn’t reach the market on science alone.
Before approval, sponsors must navigate a highly structured regulatory pathway, from determining submission requirements and preparing the right documentation to pre-submission meetings, screening, CTD organization, and regulatory review. If you work in or are entering Regulatory Affairs, understanding how these pieces fit together is essential.
In this introductory workshop, you’ll get a practical overview of the New Drug Submission (NDS) process and learn how to:
- Understand the key stages of drug development and approval
- Navigate the components and requirements of an NDS
- Recognize different notice types and priority review considerations
- Understand the role of pre-submission meetings
- Explore submission formatting, filing, and screening
- Understand the structure and modules of the CTD
- Learn how eCTD supports modern regulatory submissions
Rather than looking at each requirement in isolation, you’ll see how the regulatory submission process connects from drug development through filing and review, giving you a stronger foundation for working with pharmaceutical submissions.
Whether you're new to Regulatory Affairs or looking to strengthen your understanding of the NDS process, this workshop will help you build the regulatory knowledge behind bringing new drugs toward approval. *All participants will receive a Certificate of Attendance upon completion. |
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