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September 27:
| PLENARY: FDA Insights on Products for Rare Diseases and Pediatrics Eric Chen, MS; Jonathan Goldsmith, MD; Vasum Peiris, MD |
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Device Track: |
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| Overview of CDRH and Basic Submission Process Elias Mallis |
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| Resources Diane Nell, |
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| Design Controls Stanley Liu |
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| Device Clinical Trials/IDE Program Soma Kalb |
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| 501(k) Program Kimberly Piermatteo |
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| de novo Program Sergio de del Castillo |
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| PMA Program Donna Headlee |
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| Wrap Up Q&A All the Day’s Speakers |
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Drug Track: |
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| Emerging Technology Team: FDA’s Tool to Facilitate and Promote Pharmaceutical Innovation Mohan Sapru |
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| Prescribing Information: Resources, Review Process, and Guidances Under Development Eric Brodsky |
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| Application of cGMPs to Drug Product Quality Microbiology Laboratory Tests and Manufacturing Process Validation John Metcalfe |
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| BA/BE Inspections and Surveillance Arindam Dasgupta |
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| ACE/ITDS: FDA Implementation Update and Tips for Drug Importers Jean E. McCue |
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| The Drug Supply Chain Security Act (DSCSA): Implementation Updates Connie T. Jung |
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| Beyond Guidance: Formal Meetings and Requests for Information Kevin Bugin |
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September 28:
Device Track: |
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| Welcome and Overview of Day 2 Joseph Tartal |
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| Quality System Overview Aileen Velez Cabassa |
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| Management Controls Tonya Wilbon |
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| Basics of Risk Management for Quality Systems Joseph Tartal |
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| Complaints Anike Freeman |
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| FDA Medical Device Inspections Marc Neubauer |
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| Wrap Up and Q&A All the Day’s Speakers |
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Drug Track: |
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| Welcome and Introducing the New SBIA Webpages Brenda Stodart |
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| Introduction to Post-marketing Drug Safety Surveillance: Pharmacovigilance in FDA/CDER Suranjan De & Kimberly Swank |
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| Ensuring Quality over the Product Lifecycle: Risk-based Product Specific Inspections in OPQ Derek Smith |
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| Increasing the Quality and Efficiency of Clinical Trials: The Clinical Trials Transformation Initiative (CTTI) Kristen Miller |
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| Risk and Team-based Integrated Quality Assessment in the Office of Pharmaceutical Quality M. Scott Furness |
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| Best Practices for Communication Between IND Sponsors and FDA during Drug Development Rachel Hartford |
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