Agenda

Day 1 Oct 07, 2021

10:00 AM — 1:00 PM

Short Course 1: FDA Regulation of Digital Health Products - CDRH and CDER Perspectives

Day 2 Oct 13, 2021

10:00 AM — 10:40 AM

Session 1: Welcome and Keynote: Integrated Risk Management Approach for Combination Products

10:40 AM — 11:10 AM

Break/Visit Virtual Exhibit Hall

11:10 AM — 12:10 PM

Session 2: Overview of Risk Management

12:10 PM — 1:10 PM

Break/Visit Virtual Exhibit Hall

1:10 PM — 2:10 PM

Session 3: Pre-Market Stage of the Product Lifecycle

2:10 PM — 2:40 PM

Break/Visit Virtual Exhibit Hall

2:10 PM — 2:40 PM

Exhibitor Event/Non-CE: Case Study Spotlight

2:40 PM — 3:40 PM

Session 4: Risk Management and The Transfer to Operations: Including a Digital Health Perspective

3:40 PM — 4:10 PM

Break/Visit Virtual Exhibit Hall

4:10 PM — 5:10 PM

Session 5: Post-Market Stage of the Product Lifecycle

Day 3 Oct 14, 2021

9:50 AM — 10:00 AM

Welcome to Day Two

10:00 AM — 11:00 AM

Session 6: Informational Session with EU

11:00 AM — 11:15 AM

Break/Visit Virtual Exhibit Hall

11:15 AM — 12:15 PM

Session 7A Utilizing Continuous Market Feedback to Inform Future Decision Making for Your Combination Product

12:15 PM — 12:30 PM

Break/Visit Virtual Exhibit Hall

12:30 PM — 1:30 PM

Session 7B Utilizing Continuous Market Feedback to Inform Future Decision Making for Your Combination Product

1:30 PM — 2:00 PM

Break/Visit Virtual Exhibit Hall

2:00 PM — 3:30 PM

Session 8: Reacting to Market Feedback for Changes in Advanced Technology

3:30 PM — 3:45 PM

Break/Visit Virtual Exhibit Hall

3:45 PM — 5:15 PM

Session 9: Risk Management in Digital Combination Product Development and Lifecycle Management

5:15 PM — 5:15 PM

Closing Remarks

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Special Topic: Risk Management in Combination Product Development

Agenda

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