Global Wales Partnership Sponsored Webinar
From Research to FDA Approval: Insights into Regenerative Medicine Therapies and Regulatory Strategy
5th June 2025
09:00 - 10:15 AM (US Eastern Time)
02:00 - 03:15 PM (UK time)
09:00 - 10:15 PM (Beijing Time)
Lecture 1 (09:05 - 09:35)
Cell based therapies for tissue engineering and regenerative medicine
Dr. Pamela Robey, Ph.D. (NIH/NIDCR)
Followed by Q&A
Lecture 2 (09:35 - 10.05)
Navigating FDA Approval: Strategies for Success through 510(k)
Mr. Kyle Rose Rook Quality System
Followed by Q&A
Panel members:
Dr. Zhidao Xia
Centre for Nanohealth, Institute of Life Sciences, Swansea University Medical School, Singleton Park, Swasnea, SA2 8PP, UK
Prof. James Triffitt
Nuffield Department of Orthopaedics, Rheumatology and Musculoskeletal Science, Windmill Road, Oxford, OX3 7LD, UK
Zooming info:
https://swanseauniversity.zoom.us/j/8266570519?pwd=aXdrN1pOUFhqSFlSYlFkQjVvNDRHQT09
Meeting ID: 826 657 0519 Passcode: 718288
Lecture 1 (09:05 - 09:35)
Cell based therapies for tissue engineering and regenerative medicine
Dr. Pamela Robey, Ph.D. (NIH/NIDCR)
Followed by Q&A
Dr. Pamela Robey is a senior scientist at the National Institute of Dental and Craniofacial Research (NIDCR), where she leads the Skeletal Biology Section. She received her Ph.D. from the Catholic University of America and completed postdoctoral training at the NIH, focusing on lysosomal storage disorders and ocular connective tissue diseases. Since joining NIDCR in 1983, Dr. Robey has pioneered methods for culturing human bone-forming cells to study mineralized matrix formation. She has co-led the NIH Bone Marrow Stromal Cell Transplantation Center and currently serves as Acting Scientific Director of the NIH Stem Cell Characterization Facility.
probey@dir.nidcr.nih.gov
Skeletal Biology Section, NIH/NIDCR, Building 30, Room 226, 30 Convent Dr. MSC 4320, Bethesda, MD 20892-4320, United States
https://www.nidcr.nih.gov/research/conducted-at-nidcr/investigators/pamela-robey
Lecture 2 (09:35 - 10.05)
Navigating FDA Approval: Strategies for Success through 510(k)
Mr. Kyle Rose Rook Quality System
Followed by Q&A
Mr. Kyle Rose is the founder and CEO of Rook Quality Systems, a consultancy supporting startups and small medical device companies with quality management and regulatory strategy. A Certified Quality Auditor (CQA), he brings over a decade of experience with FDA, CE Mark, Health Canada, and CFDA submissions, specialising in streamlined, compliant QMS design and auditing.
info@rookqs.com
Founder/CEO, Rook Quality Systems, 1155 Mount Vernon Hwy, Suite 800, Dunwoody GA 30338
Panel members:
Dr. Zhidao Xia
Centre for Nanohealth, Institute of Life Sciences, Swansea University Medical School, Singleton Park, Swasnea, SA2 8PP, UK
Prof. James Triffitt
Nuffield Department of Orthopaedics, Rheumatology and Musculoskeletal Science, Windmill Road, Oxford, OX3 7LD, UK
