Navigating Regulatory Affairs: Pathways and Challenges
The Innovation Gateway Lunch & Learn in January will feature Dr. Iris Marklein, an Assistant Professor of Practice and Regulatory Affairs Advisor in the UGA College of Engineering, College of Pharmacy and Innovation Gateway. Iris’ overall role is to provide regulatory support to faculty, UGA-based startups and UGA initiatives in biomanufacturing, and to provide regulatory education.
Iris’ background is in regenerative medicine and regulatory affairs. After receiving her PhD from the University of Pennsylvania, she joined the Center for Devices and Radiological Health in the U.S. Food and Drug Administration (FDA), where she gained experience in navigating the regulatory framework for medical devices and also reviewed multiple device submission types, including Q-submissions, Investigational Device Exemption (IDE) applications, and 510(k) Premarket Notifications. Iris then moved to the Center for Biologics Evaluation and Research (CBER) within FDA and was able to expand her existing knowledge of medical device regulations and work on other types of products, including biologics and combination products. Most recently, Iris served as Device and Combination Products Team Lead in CBER, gaining even more exposure to a wide range of products and the complex regulatory challenges faced by novel, cross-cutting technologies.
During the Lunch & Learn, Iris will provide an overview of the FDA and regulatory pathways for different types of medical products, with a focus on devices, biologics and combination products. She will also provide some ‘best practices’ for early product development.
Thursday, Jan. 31, 2019
Noon to 1 p.m.
Center for Applied Genetic Technologies, Room 128/130
111 Riverbend Road, Athens, GA 30602
The event is free and open to the public. Lunch will be provided. RSVP to Tyler Duggins at email@example.com or 706-542-8969.
The Innovation Gateway Lunch & Learn series provides training and seminars that occur during the lunch hour. The goal is to inform and inspire individuals working with startup companies as well as those interested in issues facing university startups. Topics range from employment issues and tax credits to grant programs and intellectual property.
We need your voice in the discussion! Join us to plan a collective vision.
As the UGA innovation ecosystem gets ready to take flight, let’s make sure all of us have a chance to be onboard. Just as we’ve worked hard to make STEM more inclusive of our community, UGA innovators—and the people who support them—must ensure that innovation and entrepreneurship are not options only for the few. If you work to support innovation in your unit—or if you are innovator yourself in search of your next opportunity—we need your voice in this discussion. Please join us to learn from each other, make new connections and plan a collective vision. Working agenda coming soon!
This symposium is organized by the UGA Office of STEM Education and the UGA Office of Research.