LEVERAGING EXCELLENCE FACILITATING INNOVATION IMPACTING LIVES
CURRICULUM
WEEK 2: POLICY & REGULATION / WASHINGTON / DATES TBA
SUNDAY
DATE TBD
Arrive, Silver Springs, MD
6:00p - 3D Scholars Welcome Dinner
MONDAY
DATE TBD
Day at the FDA
Meet and Greet, Introductions
Devices
FDA Device Policy
Historical Perspective
Regulatory Pathways (overview)
510K, De Novo, PMA
Preclinical Considerations
Animal Studies & Engineering
Clinical Studies
Clinical Trial Design
Evidence Evaluation
Statistical Concerns
Post-Market Considerations
Office of Clinical Evidence and Analysis
Office of Product Evaluation & Quality
Case Study
Observations of FDA Meetings
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Group Dinner
TUESDAY
DATE TBD
Half Day at CMS
Meet and Greet, Introductions
CMS Authority and Benefit Categories
Historical Perspective
Local vs National Coverage
Coverage with Evidence Development
TCET & Other Emerging Policies
Medicaid 101 & dually eligible benefits
Case Study
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Half Day at Consulting and/or Law Firm
​
Group Dinner
WEDNESDAY
DATE TBD
Morning at the Patent Office
Afternoon Debrief, Homework, Planning and Goal Setting
Evening Departures
THURSDAY
DATE TBD
Departures