Download presentation
Presentation is loading. Please wait.
1
Lessons Learned from the Mistakes of Others
Susan Alpert, Ph.D., M.D. Senior Vice President Chief Quality and Regulatory Officer Medtronic MD
2
Pediatrics New Population? New Claim? New Intended Use?
New Legislation in Congress
3
What You Already Have Pre-clinical data applicable to population
Adult data that is relevant and usable Understanding of special pediatric issues Disease related Growth related Development related Plans for post-market evaluation Plans for consultants and FDA interaction
4
Contract Research Organization What to Know
Expertise and Experience Types of trials Data management Investigation center support History with FDA Submission Audits
5
Contract Research Organization What to Do
Select Check references See work Monitor Your staff capability Your plan and responsibility Your expectations Audit Who can do this Have a plan Support!
Similar presentations
© 2025 SlidePlayer.com. Inc.
All rights reserved.