The 10th Annual UGA-FDA Medical Device Regulations Conference
University of Georgia Center for Continuing Education & Hotel, Athens, GA
Registration (Virtual and In-person)
November 28-29, 2023 (Conference)
November 30, 2023 (Workshop*)
PROGRAM HIGHLIGHTS
Early registration through October 27, 2023, with up to $100 in savings!
Overview
The University of Georgia’s International Biomedical Regulatory Sciences Program (UGA) and
US Food and Drug Administration (FDA) are co-sponsoring the 10th Annual UGA-FDA Medical
Device Joint Regulatory Conference (UGA-FDA MDRC).
Attend virtually or in-person with your peers and experts during this premier conference which
provides educational and networking opportunities to help shape and advance the future of
medical device regulatory sciences. Using a tutorial approach, experienced leaders from the
FDA, Notified Bodies, and medical device industry experts will present and engage the audience
on challenges related to medical device compliance and quality areas. International
collaboration efforts that improve quality and benefit the public are also highlighted.
UGA-FDA MDRC will offer insights into many of the challenges faced by industry and regulators
regarding the following topics:
- EUA’s for medical devices related to COVID
- Pre-market challenges
- Communicating effectively with FDA
- Real world data for medical devices
- China & EU regulatory updates
- Compliance and enforcement trends
We look forward to seeing you November 28-29, 2023, at the 2023 UGA-FDA MDRC!
UGA Sponsored Workshop (November 30*)
Workshop Topic: Global Development of Combination Products
The regulatory landscape surrounding the manufacturing and distribution of Combination Products poses significant complexities both in the United States and Europe. These combination products, can offer numerous advantages in terms of convenience, accuracy, and reduced risk of contamination. However, the regulatory frameworks governing these products in the two regions present challenges for manufacturers, regulators, and patients. The workshop will explore and highlight the key regulatory complexities associated using several examples of combination products both in the United States and Europe. With this learning the workshop attendees will work in groups to define regulatory strategy and requirements on an example combination product.
* Workshop solely sponsored by UGA