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May 9:
| KEYNOTE Ingrid Zambrana |
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| PLENARY: Regulatory Research at FDA Ksenia Blinova and Alexandre Ribeiro |
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Device Track: |
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| Day 1 Introductions Elias Mallis |
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| Animal Study Considerations Judith A. Davis |
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| Biocompatibility Jennifer Goode |
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| Device Clinical Trials/IDE Program Soma Kalb |
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| 510(k) Program: Overview Kimberly Piermatteo |
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| 510(k) Program: Case Study Kimberly Piermatteo |
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| Introduction to the Premarket Approval (PMA) Program Donna Headlee |
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Drug Track: |
| Introduction to Investigational New Drug (IND) Applications Kevin B Bugin |
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| Expanded Access INDs, Process Overview, and What’s New Kevin B Bugin |
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| Regulatory and Administrative Components of an IND Application Maureen Dillon-Parker |
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| Benefit-Risk Considerations in Drug Development Charu Mullick |
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| Review of Chemistry, Manufacturing Controls (CMC) of an Investigational New Drug (IND) Application Maria Cecilia Tami and Balajee Shanmugam |
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May 10:
Device Track: |
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| Day 2 Introductions Joseph Tartal |
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| Introduction to the Quality System Regulation Aileen Velez Cabassa |
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| Risk in the Quality System Joseph Tartal |
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| Nonconformances Vidya Gopal |
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| Complaints Stanley Liu |
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| Medical Device Reporting Anike Freeman |
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| Regulatory Actions Tonya Wilbon |
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| FDA Medical Device Inspections Dawn M. Braswell |
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Drug Track: |
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| Now You Are Ready to Submit Your (IND) Application | Clinical Hold Judit Milstein |
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| Overview of Non-clinical Assessment in Drug Development Hanan Ghantous |
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| General Sponsor Responsibilities Faranak Jamali |
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| General Clinical Investigator Responsibilities Faranak Jamali |
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| Walkthrough of an FDA Inspection Nicole M. Bell |
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| Additional Sponsors’ Responsibilities Judit Milstein |
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| FDA Communication Pathways During Drug Development Rachel Brown Kichline |
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