Join us for this SPECIAL SESSION taking place during DIA Global 2022. This is a cocktail reception with presentation and Q&A hosted by Julie Bullock, PharmD & ex FDA and Demetrius Carter at the Hyatt Regency McCormick Place.
Given the launch of Project Optimus, how do you best navigate the evolving regulatory landscape and determine the optimal way to engage with the agency? Join this special event at DIA 2022 to address key questions that will help you to create a plan that’s tailored to your needs, whether you are at pre-IND stage or already in the clinical phases.
- What is the actual ask from the FDA on Project Optimus?
- When should you engage with the agency?
- What should you talk about with the agency and how should you prepare?
- What are best practices for your regulatory engagement and submission?
Location: Prairie Room located on the 2nd floor of the Hyatt Conference Center