Working Within Regulatory Boundaries to Win in Medical Product Development
Erika Segear, Ph.D. RAC
Associate Director of Regulatory Affairs, Duke University
Sponsored by MEDx, Duke Engineering Entrepreneurship, and Duke Innovation and Entrepreneurship
11 a.m. - 3 p.m. (lunch provided)
Saturday, January 11, 2020
Schiciano Auditorium, Fitzpatrick Center, Duke University
Registration is required: https://duke.qualtrics.com/jfe/form/SV_74cuIWUSexH5Tp3
Attendance is limited to 50
If you have any questions or after registering you find that you will be unable to attend, contact Donna Crenshaw at firstname.lastname@example.org.
Please be considerate and attend if you register.
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 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 works with a team of Regulatory Affairs professionals who support the clinical research community at Duke University. Dr. Segear 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 oversees and manages implementation of new educational, operational, and collaborative initiatives within ORAQ.
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