Regulatory Boot Camp at MITM 2025

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!

For additional information and to register, visit the MITM 2025 event website.

Feel free to reach out with any questions.