Name: Advancing Innovation through Essential Drug Delivery Design Outputs
Start: 2025-06-16T11:00:00-0400
End: 2025-06-16T12:00:00-0400

Monday June 16, 2025 11:00am - 12:00pm EDT

TBD

Component Type: Forum
Level: Intermediate

This session will explore this new regulatory tool (EDDOs) and discuss its impact on the next generation of drug delivery combination products.

Learning Objectives

Understand what an Essential Drug Delivery Design Output is and compare it to other CMC terminology, including Critical Quality Attributes (CQA), Established Conditions, Primary Function, and Essential Performance; Analyze current challenges facing novel combination products; Review key guidance highlights, including submission expectations (IND, NDA/BLAs), Control Strategy, Post-market changes, verification, and validation testing.

Chair

Rumi Raquel Young, MS

Speakers

Rumi Young

Director, Regulatory Policy, Novo Nordisk, United States

Rumi Young is the Director of Regulatory Policy at Novo Nordisk, ensuring future growth and innovation by promoting effective biopharmaceutical policies. Previously, she led BD’s Global Regulatory Policy team to shape future policies for medical devices, diagnostics, and combination... Read More →

Monday June 16, 2025 11:00am - 12:00pm EDT
TBD Walter E. Washington Convention Center 801 Allen Y. Lew Place, NW Washington, DC 20001-3614 USA

06: PersonalizedMed-ComboProd-Diagnostics, Forum

Level Intermediate
Level Intermediate
format csv
Tags Forum

DIA 2025 Global Annual Meeting

Rumi Young

Sign up or log in to save this to your schedule, view media, leave feedback and see who's attending!