December 9, 2017
11:00am - 3:00pm
December Entrepreneur’s Workshop on Medical Regulation
Working within regulatory boundaries to win in medical product development
Sponsored by Engineering Entrepreneurial Ventures and MEDx
11 am – 3 pm (lunch provided)
Saturday, December 9, 2017
Schiciano Auditorium, Fitzpatrick Building, Duke University
If after registering you find that you will be unable to attend, please contact Donna Crenshaw at firstname.lastname@example.org.
Part 1. Regulation of investigational medical products
Presenter: Erika Segear Johnson, PhD, RAC
This workshop will discuss the regulation of investigational medical products by the U.S. Food and Drug Administration (FDA). It will give an overview of FDA’s role in regulating medical products and it will offer guidance on how to classify your product and determine the regulatory requirements that apply. The workshop will offer a deeper dive into medical devices, discussing marketing pathways and the application process for clinical studies using unapproved devices. Case scenarios will be presented to enhance learning and stimulate audience participation. This workshop will address the following questions (and more):
- How does the FDA regulate medical products?
- Is my product a drug, device or biologic?
- How do I classify my medical device?
- What is FDA’s approach to regulating the commercialization of medical devices?
- What are the benefits of a pre-submission meeting with the FDA?
- What is the difference between an abbreviated and “full” IDE and when is the “full” IDE applicable?
- What information needs to be included in an IDE?
Dr. Segear Johnson is the Associate Director of Regulatory Affairs in the Office of Regulatory Affairs and Quality (ORAQ) within the Duke University School of Medicine. In this role, Dr. Segear Johnson works with a team of Regulatory Affairs professionals who serve as a no cost resource to the clinical research community at Duke University.
Dr. Segear Johnson is responsible for providing guidance and support to Duke sponsor-investigators in various aspects of regulatory affairs, including regulatory strategy development, preclinical testing, product manufacturing, FDA meetings, regulatory submissions, and regulatory education. She assists project teams with the development, coordination, and implementation of complex regulatory projects in a variety of therapeutic areas, including drugs, biologics, devices, tobacco products and dietary supplements. She has conducted numerous meetings with the FDA and her regulatory experience ranges from early Phase 1 activities through late stage product development. In addition to regulatory work, Dr. Segear Johnson oversees and manages implementation of new educational, operational, and collaborative initiatives within ORAQ.
Part 2. Hi, I’m from the IRB – and I’m here to help you
Presenter: George Cianciolo, PhD
George came to Duke in 1978 and after several years joined the faculty as an Assistant Professor in the Rheumatology Division of the Department of Medicine and an Assistant Investigator with the Howard Hughes Medical Institute. He left in 1987 to join Genentech, where he was Group Leader – Immunobiology, and after several years returned to the Triangle to join a Duke startup, Sphinx Biotechnologies, as Director of Development. He later co-founded another Duke startup, Macronex Inc., as Executive VP of R & D. George returned to Duke as an Associate Professor of Pathology and has served a combined 17 years on two Duke IRB boards and recently became an IRB Chair. He lives in Chapel Hill with his wife of 47 years and their two dogs and is currently finishing up his term as a member of the Chapel Hill Town Council.