SBIA Education Events

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

REdI Conference 2018 – Files

Download the Keynote Slides

Download the Plenary Slides

Download the Agenda

Evaluation & Certificate

May 15, 2018

KEYNOTE
Steven E. Porter
(Slides available above after the presentation)
View Recording
PLENARY: Role of Human Factors Engineering in Medical Products Regulatory Reviews and Research
Kimberly Kontson and Quynh Nhu Nguyen
Download slides above
View Recording

Device Track:

Day 1 Introductions
Elias Mallis
Slides in ZIP file above
View Recording
Medical Device Framework
Donna Headlee
Slides in ZIP file above
View Recording
Successful Clinical Trial Strategies
Stanley Liu
Slides in ZIP file above
View Recording
CDRH BIMO Inspections
Marisa M. White
Slides in ZIP file above
View Recording
510(k) Program: Case Study
Kimberly Piermatteo
Slides in ZIP file above
View Recording
De Novo Classification Requests
Sergio de del Castillo
Slides in ZIP file above
View Recording
Fostering Digital Health Innovation: FDA’s approach to Mobile Apps
Simon Choi
Slides in ZIP file above
View Recording

Drug Track:

Demystifying the Investigational New Drug (IND) Application for Drugs and Biologics
Kevin B. Bugin
Slides in ZIP file above
View Recording
Formal Meetings for PDUFA Products and Best Practices for Communication During Drug Development
Rachel Brown Kichline
Slides in ZIP file above
View Recording
IND Submission: Content/Format and First 30 Days
Maureen Dillon-Parker and Judit Milstein
Slides in ZIP file above
View Recording
Overview and Differences in Nonclinical Safety Assessment for Small Molecules and Biologic Drug Development
Hanan Ghantous
Slides in ZIP file above
View Recording
Chemistry, Manufacturing Controls (CMC) Requirements for an IND Application
Maria Cecilia Tami and Chunchun Zhang
Slides in ZIP file above
View Recording

May 16, 2018:

Device Track:

Day 2 Introductions
Joseph Tartal
Slides in ZIP file above
View Recording
An Introduction to the Quality System Regulation and Design Controls
Tonya A. Wilbon
Slides in ZIP file above
View Recording
User Needs, Design Input, Design Output and Design Review/b>
Vidya Gopal
Slides in ZIP file above
View Recording
Design Verification/Validation and Risk Analysis
Joseph Tartal
Slides in ZIP file above
View Recording
Design Transfer and Design Change Controls
Andrew Durfor
Slides in ZIP file above
View Recording
UDI Update – 2018
Loretta Chi
Slides in ZIP file above
View Recording
Medical Device Reporting
Anike Freeman
Slides in ZIP file above
View Recording
FDA Medical Device Inspections
Maida Henesian
Slides in ZIP file above
View Recording

Drug Track:

Benefit-Risk Considerations During Drug Product Development
Charu Mullick
Slides in ZIP file above
View Recording
FDA Regulatory Requirements for Clinical Investigators and Case Examples
Faranak Jamali
Slides in ZIP file above
View Recording
IND Safety Reporting requirements
Yuliya Yasinskaya
Slides in ZIP file above
View Recording
Good Manufacturing Practices (GMPs) from an IND Perspective
Maria Cecilia Tami
Slides in ZIP file above
View Recording
Overview of SBIA
Renu Lal
Slides in ZIP file above
View Recording
The Active IND and Available Development Programs
Judit Milstein and Maureen Dillon-Parker
Slides in ZIP file above
View Recording
Walkthrough of a Pre-Approval Manufacturing Site Inspection
Lucila B. Nwatu
Slides in ZIP file above
View Recording