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RAPS Convergence 2023

RAPS Convergence 2023

We are excited to be presenting at this conference

eCTD Module 3, How Much Detail Do I Submit?

Robert L. Waterland, PhD

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Principal Regulatory Writer

This seminar will provide a high-level overview of the expectations required for Module 3 submissions for a small molecule oral solid product NDA, a parenteral biologic BLA, and a vaccine BLA. We will start with the small molecule oral solid, move to the biologic, then finish with the vaccine.

Sponsored Presentation: What’s Next: The Evolution of Regulatory Submissions and Technology

Heather Graham, Vice President, Regulatory Science and Medical Affairs & Trevor Standish, Director, Product Management

In our pursuit to bring medicines to patients faster, we must continuously evolve alongside an endlessly changing regulatory landscape. For Regulatory Professionals, this translates into increased complexity, additional requirements, and less time for submission preparation. This session will explore the past and future of regulatory submissions, from the perspective of the Regulatory Professional. Together, we will discuss how both processes and technologies are evolving.