PLENARY: FDA Insights on Products for Rare Diseases and Pediatrics Eric Chen, MS; Jonathan Goldsmith, MD; Vasum Peiris, MD | Slides in ZIP file above Recording |
Device Track: | |
Overview of CDRH and Basic Submission Process Elias Mallis | Slides in ZIP file above Recording |
Resources Diane Nell, | Slides in ZIP file above Recording |
Design Controls Stanley Liu | Slides in ZIP file above Recording |
Device Clinical Trials/IDE Program Soma Kalb | Slides in ZIP file above Recording |
501(k) Program Kimberly Piermatteo | Slides in ZIP file above Recording |
de novo Program Sergio de del Castillo | (No slides for this session) Recording |
PMA Program Donna Headlee | Slides in ZIP file above Recording |
Wrap Up Q&A All the Day’s Speakers | (No slides for this session) Recording |
Drug Track: | |
Emerging Technology Team: FDA’s Tool to Facilitate and Promote Pharmaceutical Innovation Mohan Sapru | Slides in ZIP file above Recording |
Prescribing Information: Resources, Review Process, and Guidances Under Development Eric Brodsky | Slides in ZIP file above Recording |
Application of cGMPs to Drug Product Quality Microbiology Laboratory Tests and Manufacturing Process Validation John Metcalfe | Slides in ZIP file above Recording |
BA/BE Inspections and Surveillance Arindam Dasgupta | Slides in ZIP file above Recording |
ACE/ITDS: FDA Implementation Update and Tips for Drug Importers Jean E. McCue | Slides in ZIP file above Recording |
The Drug Supply Chain Security Act (DSCSA): Implementation Updates Connie T. Jung | Slides in ZIP file above Recording |
Beyond Guidance: Formal Meetings and Requests for Information Kevin Bugin | Slides in ZIP file above Recording |
Device Track: | |
Welcome and Overview of Day 2 Joseph Tartal | Slides in ZIP file above Recording |
Quality System Overview Aileen Velez Cabassa | Slides in ZIP file above Recording |
Management Controls Tonya Wilbon | Slides in ZIP file above Recording |
Basics of Risk Management for Quality Systems Joseph Tartal | Slides in ZIP file above Recording |
Complaints Anike Freeman | Slides in ZIP file above Recording |
FDA Medical Device Inspections Marc Neubauer | Slides in ZIP file above Recording |
Wrap Up and Q&A All the Day’s Speakers | (No slides for this session) Recording |
Drug Track: | |
Welcome and Introducing the New SBIA Webpages Brenda Stodart | (No slides for this session) Recording |
Introduction to Post-marketing Drug Safety Surveillance: Pharmacovigilance in FDA/CDER Suranjan De & Kimberly Swank | Slides in ZIP file above Recording |
Ensuring Quality over the Product Lifecycle: Risk-based Product Specific Inspections in OPQ Derek Smith | Slides in ZIP file above Recording |
Increasing the Quality and Efficiency of Clinical Trials: The Clinical Trials Transformation Initiative (CTTI) Kristen Miller | Slides in ZIP file above Recording |
Risk and Team-based Integrated Quality Assessment in the Office of Pharmaceutical Quality M. Scott Furness | Slides in ZIP file above Recording |
Best Practices for Communication Between IND Sponsors and FDA during Drug Development Rachel Hartford | Slides in ZIP file above Recording |