SBIA Education Events

US FDA – Center for Drug Evaluation & Research – Small Business & Industry Assistance

REdI Spring Conference 2017 – Files

Download the Agenda

Event Evaluation & Certificate of Attendance

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:

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:

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:

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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