REdI Fall Conference 2017 – Files

Download the Agenda

KEYNOTE Anna K. Abram	(No slides for this presentation) View Recording
PLENARY: Regulatory Research at FDA Ksenia Blinova and Alexandre Ribeiro	Slides in ZIP file above View Recording
Device Track:
Day 1 Introductions Elias Mallis	Slides in ZIP file above View Recording
Animal Study Considerations Judith A. Davis	Slides in ZIP file above View Recording
Biocompatibility Jennifer Goode	Slides in ZIP file above View Recording
Device Clinical Trials/IDE Program Soma Kalb	Slides in ZIP file above View Recording
510(k) Program: Overview Kimberly Piermatteo	Slides in ZIP file above View Recording
510(k) Program: Case Study Ángel Soler-García	Slides in ZIP file above View Recording
Introduction to the Premarket Approval (PMA) Program Donna Headlee	Slides in ZIP file above View Recording
Drug Track:
Introduction to Investigational New Drug (IND) Applications Kevin B. Bugin	Slides in ZIP file above View Recording
FDA Communication Pathways Rachel Kichline	Slides in ZIP file above View Recording
Content and Format of an Initial IND Submission Maureen Dillon-Parker	Slides in ZIP file above View Recording
Benefit-Risk Considerations in Drug Development Charu Mullick	Slides in ZIP file above View Recording
Review of Chemistry, Manufacturing Controls (CMC) of an Investigational New Drug (IND) Application Maria Cecilia Tami and Balajee Shanmugam	Slides in ZIP file above View Recording

Device Track:
Day 2 Introductions Joseph Tartal	Slides in ZIP file above View Recording
Introduction to the Quality System Regulation Aileen Velez Cabassa	Slides in ZIP file above View Recording
Risk in the Quality System Joseph Tartal	Slides in ZIP file above View Recording
Nonconformances Vidya Gopal	Slides in ZIP file above View Recording
Complaints Stanley Liu	Slides in ZIP file above View Recording
Medical Device Reporting Anike Freeman	Slides in ZIP file above View Recording
Regulatory Actions Tonya Wilbon	Slides in ZIP file above View Recording from the Spring 2017 Conference
FDA Medical Device Inspections Thomas A. Peter	Slides in ZIP file above View Recording
Drug Track:
Overview of Non-clinical Assessment in Drug Development Hanan Ghantous	Slides in ZIP file above View Recording
Initial IND Submission: First 30 Days Judit Milstein	Slides in ZIP file above View Recording
Active IND Sponsor’s Responsibilities Judit Milstein	Slides in ZIP file above View Recording
Overview of Clinical Investigator Responsibilities Faranak Jamali	Slides in ZIP file above View Recording
Walkthrough of an FDA Inspection Nicole M. Bell	Slides in ZIP file above View Recording
Overview of FDA’s Expanded Access Program J. Paul Phillips	Slides in ZIP file above View Recording
Live Demo of the FDA Adverse Events Reporting System Public Dashboard Sanjay K. Sahoo	Slides in ZIP file above View Recording