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*)
*Workshop solely sponsored by UGA
Conference Speakers
Nelson Anderson
Nelson Anderson is a biomedical engineer and IT product owner at the FDA. He was a lead reviewer in CDRH for cardiovascular devices for 13 years before moving into the IT realm 7 years ago and is now the platform owner for the CDRH Portal among other duties. Nelson has maintained his sanity through 20 years in the federal government by traveling and geocaching around the world, having recently returned from climbing Kilimanjaro.
Blake Bevill, Program Division Director
Division 2, Office of Medical Device and Radiological Health Operations
Blake has been with the Food and Drug Administration since 1989. He was an Investigator for 12 years which included conducting foreign inspections. He accepted a Supervisory Investigator position in 2001. Following his participation in the FDA Leadership Program in 2005 and 2006 he became an Operations Director and worked directly with the Associate Commissioner for Regulatory Affairs and other agency leaders involved in ORA strategic planning, budgeting, and organizational initiatives. He became the Director of Compliance for Los Angeles District in 2009 and assumed the Director of Compliance position in Florida District in 2014. He is currently the Program Division Director for Division 2 Central within the Office of Medical Device and Radiological Health Operations. As the Director of Division 2 Central, he leads all device inspectional and compliance activities that formerly resided in the seven District Offices of ATL-DO, CHI-DO, FLA-DO, KAN-DO, MIN-DO, NOL-DO, and SJN-DO. He graduated from Harding University with a Bachelor’s degree in Biology, Arkansas State University with a Master’s of Science degree in Biology, and completed a Senior Executive Development program at George Washington University.
Evangeline Loh, Ph.D.
Evangeline Loh, Ph.D., RAC (US, EU) , Emergo by UL, Manager, Global Quality & Regulatory AffairsDuring her over 17 year tenure at Emergo by UL, Evangeline has assisted hundreds of manufacturers with global regulatory strategy, registration and consulting projects. Evangeline’s areas of expertise include European CE Marking, clinical evaluation reports, and now performance evaluation reports, global vigilance, and device classification in markets worldwide. She has been intimately involved in the EU transition from the Directives to the Regulations, and all the related regulatory requirements. Evangeline is a key architect in developing tools for Emergo’s Regulatory Affairs Management Suite (RAMS) software. She has most recently been tasked with advancing the organization’s Thought Leadership presence, as well more visibly sharing Emergo by UL’s global regulatory expertise. She previously worked for Cook Medical as a regulatory scientist and at a non profit lobbying for medical schools. She has her Regulatory Affairs Certification (RAC), US and EU, in the days before there were discipline specific RACs, holds a Ph.D. in pharmacology from The University of Texas Health Sciences Center at San Antonio, and a B.S. in microbiology from Cornell University. While she would purport that has no spare time, if she did, she would enjoy contemplating methods of how to be more efficient, working-out as a means to enjoy food, and traveling for leisure.
Mark R. Prausnitz
Mark R. Prausnitz is Regents’ Professor, Regents’ Entrepreneur and J. Erskine Love, Jr. Chair in Chemical & Biomolecular Engineering at the Georgia Institute of Technology. He carries out research on biophysical methods of drug delivery using microneedles, lasers, ionic liquids and other microdevices for transdermal, ocular and intracellular delivery of drugs and vaccines. He has published more than 330 journal articles and has co-founded eight start-up companies including Micron Biomedical and Clearside Biomedical.
Helin Räägel, PhD
Dr. Helin Räägel is the scientific thought leader and a senior biocompatibility expert for the Expert Advisory Services division within Nelson Labs. Her work focuses on assisting medical device manufacturers to find creative and scientifically sound solutions in their approach to biological evaluations targeted for regulatory submissions around the world. She is an active member of ASTM and ISO working groups focusing on biological safety assessments. She is passionate about the intersection of science and biocompatibility and frequently contributes to the global conversation around the risk-based approach to medical device biocompatibility in the form of published articles and webinars.
Helin has a PhD in molecular cell biology. Her successful academic career was highlighted by an Alexander von Humboldt Fellowship in Germany, and later by a Marie Curie Fellowship, research awards which are competitive on a global scale.