Download the Keynote Slides
Download the Plenary Slides
Download the Agenda
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 |