Name
G854a - Master Course: Medical Device Clinical Research: Hot Topics, Regulatory Updates & New Normals (Part 1)
Date & Time
Sunday, May 1, 2022, 11:00 AM - 2:00 PM
Description
This interactive program is designed for medical device professionals who deal with complex issues, need to understand the latest developments, and can contribute their own front-line experiences.
Learning Objectives
- Discuss EU MDR Updates and recent US FDA Guidance released.
- Define the challenges with use of Real-World Evidence in Regulatory submissions.
- Explore FDA’s Medical Device Development Tools to facilitate device development, timely evaluation of medical devices, and promote innovation.
Speakers
Kimberly A. Dorsch - Sr. Director, Clinical Affairs - Hemanext (Speaker, Leader)
Glenda Guest - President - Assured of Quality Consulting & Training (Speaker, Chair)
Adelina Paunescu - VP of Clinical Affairs - MEDIcept (Speaker)
Glenda Guest - President - Assured of Quality Consulting & Training (Speaker, Chair)
Adelina Paunescu - VP of Clinical Affairs - MEDIcept (Speaker)
Track
G - Special Topics
Location Name
Independence East