Icon Legend

This session is not in your schedule.

This session is in your schedule. Click again to remove it.

Presentation Icons

Requires Pre-Registration or Sign-up

Additional Registration Fee

Invitation Only

Student Program

Networking Opportunity

RAPS Focus Area

715 Views

Evaluation ViewAttendees 51

Devices (includes Medical Devices and In Vitro Diagnostics)

Understand the Evolving Role of Real World Evidence

Thursday, October 5, 2023

3:30 PM - 4:30 PM EDT

Location/Room: 513B

Moderator(s)

Olga van Grol-Lawlor, MPhil

Senior Global Regulatory Intelligence & Advocacy Manager
Boston Scientific, Netherlands

Slides

Presenter (Remote)(s)

Daniel Caños, PhD, MPH

Director, Office of Clinical Evidence and Analysis, Office of Product Evaluation and Quality, CDRH
US Food and Drug Administration

Slides

Presenter(s)

Heather M. Colvin, MPP

Director, Evidence & Outcomes Policy
Johnson & Johnson MedTech

Slides

Speaker(s)

Sabina L. Hoekstra -van den Bosch, PharmD FRAPS

Global Director Regulatory Strategy
TÜV SÜD Medical Health Services, Netherlands
Monika McDole-Russell, MS, RAC

Sr. Director, Global Regulatory Affairs
Medtronic Endoscopy

Real world evidence provides invaluable information and insights into everyday clinical practice. From early-stage development to post market activities, regulators and manufacturers share challenges and opportunities for using real world evidence to support regulatory submissions.