PLENARY: Drug / Device Combinations: a Union to Deliver the Best Medical Product to Patients James Bertram & Kristina J. Lauritsen, Ph.D. | Slides in ZIP file above Click Here for Recording |
Device Track: | |
Device Classification Overview William M. Sutton | Slides in ZIP file above Click Here for Recording |
Device Clinical Trials and the IDE Program Soma Kalb, Ph.D. | Slides in ZIP file above Click Here for Recording |
The 510(k) Program LCDR Kimberly Love Piermatteo | Slides in ZIP file above Click Here for Recording |
Best Practices & Interactions w/CDRH Sergio M. de del Castillo | Slides in ZIP file above Click Here for Recording |
Labeling Overview Eric Richardson | Slides in ZIP file above Click Here for Recording |
Wrap Up and Q&A All the Day’s Speakers | (No slides for this session) Click Here for Recording |
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 | Slides in ZIP file above Click Here for Recording |
Good Clinical Practice (GCP) Inspectional Perspective on Use of Electronic Records and Signatures in Clinical Trials Kassa Ayalew, M.D., M.P.H. | Slides in ZIP file above Click Here for Recording |
Comparing Safety Report Requirements for Pre and Post Market Chrissy J. Cochran, Ph.D. | Slides in ZIP file above Click Here for Recording |
Pediatric Drug Development: Regulatory Expectations Alyson Karesh | Slides in ZIP file above Click Here for Recording |
Clinical Outcome Assessment Implementation in Clinical Trials Jessica Voqui, PharmD, M.S. | Slides in ZIP file above Click Here for Recording |
Device Track: | |
Overview of Quality Systems Regulation Tonya A. Wilbon | Slides in ZIP file above Click Here for Recording |
Design Controls Stanley Liu | Slides in ZIP file above Click Here for Recording |
Purchasing Controls Aileen Velez-Cabassa | Slides in ZIP file above Click Here for Recording |
Process Validation Joseph Tartal | Slides in ZIP file above Click Here for Recording |
Unique Device Identification (UDI) Loretta E. Chi, JD | Slides in ZIP file above Click Here for Recording |
Electronic Medical Device Reporting (eMDR) Andrew Xiao | Slides in ZIP file above Click Here for Recording |
FDA Medical Device Inspections Marc Neubauer, B.S., M.A. | Slides in ZIP file above Click Here for Recording |
Wrap Up and Q&A All the Day’s Speakers | (No slides for this session) Click Here for Recording |
Drug Track: | |
Overview of FDA Expedited Programs with a Focus on the Breakthrough Therapy Miranda Raggio, BA, BSN, MA | Slides in ZIP file above Click Here for Recording |
FDA’s Pre-Approval Inspection (PAI) Program and How to prepare for a successful outcome Denise DiGiulio, R.Ph. | Slides in ZIP file above Click Here for Recording |
CDER Regulatory Applications – Investigational New Drug and New Drug Applications Balajee Shanmugam | Slides in ZIP file above Click Here for Recording |
Lifecycle Management of Drug Products: FDA’s Perspective Geoffrey Wu, Ph.D. | Slides in ZIP file above Click Here for Recording |
Lifecycle Management of Drug Products Hasmukh B. Patel, Ph.D. | Slides in ZIP file above Click Here for Recording |
Evidence and Data Requirements for NDA Submissions Eileen Navarro, M.D., FACP | Slides in ZIP file above Click Here for Recording |
Demystifying Interactions with FDA-CDER: A Primer on Formal Meetings and Best Practices Judit Milstein | Slides in ZIP file above Click Here for Recording |