FDA’s New Final Rule for Electronic Drug Registration and Listing: What’s Changing? What’s Not?
This Solution Provider Webinar is brought to you by DIA in cooperation with Reed Tech
This session will provide an overview of FDA requirements for electronic registration and listing for drug products regulated by CDER, CBER, and CVM, based on the release of a Final Rule in 2016. We will examine the evolution of the eDRL system and cover changes introduced in the Final Rule. We will also review the impact to industry in the regulatory, compliance, and labeling arenas.
- eDRL System Background and Overview
- Recent Changes to eDRL System Based on Final Rule
- How eDRL Impacts Labeling Teams
Who should attend?
Professionals who work in the area of:
- Regulatory Affairs, including Registration and Listing
- Quality Assurance
At the conclusion of this on demand webinar, participants should be able to:
- Recognize the significance and purpose of FDA’s eDRL system
- Articulate at a high-level the electronic drug registration and listing requirements
- Assess the implications of the Final Rule for their teams and wider organizations
- Explore the topic more deeply using valuable resources from FDA and other sources