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Lessons Learned from the Mistakes of Others

Published byCandice McCoy Modified over 6 years ago

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Presentation on theme: "Lessons Learned from the Mistakes of Others"— Presentation transcript:

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!

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