The 10th Annual UGA-FDA Medical Device Regulations Conference
University of Georgia Center for Continuing Education & Hotel, Athens, GA
November 30, 2023 – Workshop* Virtual and In-person
*Workshop solely sponsored by UGA
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.