SBIA Education Events

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

REdI Fall 2015 Conference – Files Page

Download the Agenda

The session recordings will be available to registered participants only.

September 29:

PLENARY: Drug / Device Combinations: a Union to Deliver the Best Medical Product to Patients
James Bertram & Kristina J. Lauritsen, Ph.D.
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Device Track:

Device Classification Overview
William M. Sutton
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Device Clinical Trials and the IDE Program
Soma Kalb, Ph.D.
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The 510(k) Program
LCDR Kimberly Love Piermatteo
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Best Practices & Interactions w/CDRH
Sergio M. de del Castillo
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Labeling Overview
Eric Richardson
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Wrap Up and Q&A
All the Day’s Speakers
(No slides for this session)
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Drug Track:

Safety Considerations for Product Design, Container Labels, and Carton Labeling and Best Practices in Developing Proprietary Names for Drugs
Lubna Merchant, M.S., PharmD
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Good Clinical Practice (GCP) Inspectional Perspective on Use of Electronic Records and Signatures in Clinical Trials
Kassa Ayalew, M.D., M.P.H.
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Comparing Safety Report Requirements for Pre and Post Market
Chrissy J. Cochran, Ph.D.
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Pediatric Drug Development: Regulatory Expectations
Alyson Karesh
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Clinical Outcome Assessment Implementation in Clinical Trials
Jessica Voqui, PharmD, M.S.
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September 30:

Device Track:

Overview of Quality Systems Regulation
Tonya A. Wilbon
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Design Controls
Stanley Liu
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Purchasing Controls
Aileen Velez-Cabassa
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Process Validation
Joseph Tartal
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Unique Device Identification (UDI)
Loretta E. Chi, JD
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Electronic Medical Device Reporting (eMDR)
Andrew Xiao
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FDA Medical Device Inspections
Marc Neubauer, B.S., M.A.
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Wrap Up and Q&A
All the Day’s Speakers
(No slides for this session)
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Drug Track:

Overview of FDA Expedited Programs with a Focus on the Breakthrough Therapy
Miranda Raggio, BA, BSN, MA
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FDA’s Pre-Approval Inspection (PAI) Program and How to prepare for a successful outcome
Denise DiGiulio, R.Ph.
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CDER Regulatory Applications – Investigational New Drug and New Drug Applications
Balajee Shanmugam
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Lifecycle Management of Drug Products: FDA’s Perspective
Geoffrey Wu, Ph.D.
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Lifecycle Management of Drug Products
Hasmukh B. Patel, Ph.D.
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Evidence and Data Requirements for NDA Submissions
Eileen Navarro, M.D., FACP
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Demystifying Interactions with FDA-CDER: A Primer on Formal Meetings and Best Practices
Judit Milstein
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