Impacts of Artificial Intelligence on the Development of Medical Product

In this webinar, Diane Earp, Vice President, Corporate Regulatory Compliance, at Research Triangle Institute, will discuss the evolving capabilities of Artificial Intelligence (AI) in MedTech development including its impact on clinical trials, new medical devices, drug efficacy, pharmacovigilance, and robotics. This presentation is developed for innovators engaged in product development and seeks to provide considerations and potential implications of the rise of AI on your development, manufacturing, and regulatory process. Time will be allotted for questions and answers.

Presenter: Diane Earp, Vice President, Corporate Regulatory Compliance, RTI International

Presenter Diane Earp has over 25 years of experience working in regulatory affairs and quality assurance with expertise in U.S. and international regulatory requirements applicable to drug, biologics, and medical device development, testing/validation, manufacturing, and distribution.

This seminar was presented on May 17, 2023 to an invited audience.

This video is for educational purposes only.

The Catalyze program utilizes a new approach to translational research by supporting both the technical needs of an innovation and the management, commercialization, regulatory, and training requirements of the innovators developing them. Projects supported by Catalyze receive funding and advisory support through the National Heart, Lung, and Blood Institute (NHLBI), as well as project management assistance, access to technical services and expertise, and training opportunities through the Catalyze Coordinating Center.

This research was funded, in part, by the National Institutes of Health (NIH) Agreement OT2 HL157844-01. The views and conclusions of the presenters are their own and should not be interpreted as representing the official policies, either expressed or implied, of the NIH.

NHLBI Catalyze Public Site: https://nhlbicatalyze.org

Presentation Bookmarks
0:00 Welcome
1:50 What is Artificial Intelligence
5:00 Innovative Potential
7:52 Why is it Impactful
9:30 Enablers and Barriers to Healthcare Market Adaption
14:55 Current Landscape Sources of Funding
16:42 Challenges
20:53 Food and Drug Administration Perspective
23:00 US Regulatory Landscape
25:15 Popular Areas of Research Interest at FDA
28:30 Breaking News – FDA Releases Discussion Paper and Request for Feedback
30:20 Things to Consider
32:25 Questions and Answers
40:30 References
42:10 Upcoming Events and Reminders