Biofabconsulting Regulatory Boot Camp at MITM 2025 – Level 1
Join us at Meeting in the Millyard (MITM) 2025 for an in-depth Regulatory Boot Camp, taking place over two days:
Monday, May 19 – Core Boot Camp sessions led by regulatory experts from Biofabconsulting (BFC)
Tuesday, May 20 – Exclusive opportunity for Boot Camp registrants to book a free 30-minute strategy session with the BFC team (while time slots last)
What to Expect:
This Level 1 Boot Camp is designed to provide participants with a foundational understanding of how the FDA regulates human medical products. Key topics include:
FDA organizational structure & regulatory authority
Human medical product types and definitions
Basics of combination products & product jurisdiction
Overview of FDA regulatory pathways
Understanding how to use a TPP-driven, phase-appropriate approach to facilitate product development
An introduction to FDA Special Programs and designations
Strategies for optimizing meetings and communications with FDA
Bonus Opportunity: Boot Camp participants will have access to a free, 30-minute strategy session with Biofabconsulting experts on Tuesday, May 20 to discuss specific regulatory challenges and receive tailored guidance. Sessions are available on a first-come, first-served basis.
More details, including curriculum updates and speaker information, will be posted soon. Stay tuned!
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BioFabUSA, a program of ARMI, is a public-private partnership with more than 170 members, including companies, academic institutions and not-for profit organizations.