Insulin pumps that record data to a smartphone app. Autoinjectors that send data to a cloud-based website. Pills that, once ingested, send a notification to a patient’s care providers.
These are examples of smart drug/device combination products either on the market or will enter it within the next few years.
But what about regulations? Unlike traditional drug products or devices, these innovative products require developers to look beyond traditional regulatory pathways. Privacy rules, cybersecurity, and patient human factors are just some of the new types of regulations developers must consider when it comes to smart combination products.
To learn more, download the webinar presented Dec. 10, “The Ecosystem for Smart Combination Products: What About Regulations?” Napoleon Monroe, Managing Director, New Directions Technology Consulting, discusses the current state of regulations for smart combination products.
To download the webinar, click here.
What You Will Learn
- How recent industry conferences covered regulatory-related themes
- Some key industry activities related to regulation
- Challenges and opportunities affecting smart combination products
- How those themes interplay within pharma, and between other stakeholders and regulatory bodies
Who Will Benefit
This session will be valuable to not only management, regulatory, compliance, and quality personnel from companies interested in developing smart combination products, but also to any stakeholder with similar interests.
About the Presenter
Napoleon Monroe has led teams that successfully invented, developed, and commercialized combination products and medical devices. While at Survival Technology (now part of Pfizer), he helped develop and commercialize several combination products. One such product is still the primary U.S. delivery system for nerve
agent antidote.
To register for the webinar, click here.
Get a Demo
We’ll can show you insights into any of your key suppliers, FDA investigators, inspection trends, and much more.