The University of Georgia College of Pharmacy recently hosted the seventh annual Medical Device Regulations Conference on November 6-7th at UGA’s Gwinnett Campus in Lawrenceville, GA. The conference was of special interest to quality assurance and regulatory affairs professionals working in the regulated medical device industry, and it provided educational and networking opportunities to help shape the future of medical device advancement from a regulatory sciences perspective.
The Medical Device Regulations Conference has taken place annually since 2013 and is co-sponsored by the U.S. Food & Drug Administration and UGA’s Office of International Biomedical Regulatory Sciences Program. Other sponsors such as Brosseau Consulting, Network Partners, the Pipette Solution, e/NOVV, and Vero Biotech were represented as well.
According to College of Pharmacy’ Dean, Kelly Smith, "The primary goal of this conference was two-fold: to educate and to collaborate with others. I am confident these goals have been met, and you will return to your place of business with the tools you need to continue on an upward trajectory in your industry."
This year’s conference looked into the future of medical device regulatory sciences and discussed a variety of topics including FDA-CDRH and ORA updates, international updater, Artificial IntelligenceI and machine readability, and post-market surveillance. Highly experienced industry professionals and technical experts from the FDA presented on a broad range of topics. These presentations were engaging to the audience, making the conference memorable.
"A conference of this caliber with this impressive of a speaker line-up doesn’t just happen. It takes dedicated professionals who make it all come together," says Dean Smith.
Conference attendees gained a wealth of information from the FDA–including details on the single audit program, new intelligence on research and development, critical compliance issues, the FDA’s inspectional approach, and more.
Attendees learned important highlights from the European and China markets regarding international trends in the industry. They also were able to review data on the role of Artificial Intelligence and Machine Learning Software and were able to network with industry professionals.
At the close of the conference, Dean Smith updated the attendees on the College of Pharmacy. She stated that the College is in the early stages of developing a long-range strategic plan in collaboration with the University of Georgia’s efforts to forecast and plan for the future. The College of Pharmacy has also hired several new faculty members, and is continuing to enhance its outreach to the pharmaceutical and biomedical industries.
Dr. David Mullis, the founder of both the Medical Device Conference and the UGA International Biomedical Regulatory Sciences Program, was presented a special bulldog trophy in recognition of his outstanding service to the College and for establishing the Medical Device Regulations Conference. He commented that the purpose for establishing this conference was to ensure that key intelligence information would be shared with industry representatives.
Overall, the seventh annual Medical Device Regulations Conference was a success for both the attendees and the University of Georgia.
Representatives from the FDA stated, “Both industry and regulators have the same goal–to promote patient safety; and conferences like this one allow for the exchange of information and to learn from one another to promote safety of medical devices.”