概览

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.

精选主题

eDRL System Background and Overview
Recent Changes to eDRL System Based on Final Rule
How eDRL Impacts Labeling Teams

谁应该参加？

Professionals who work in the area of:

Regulatory Affairs, including Registration and Listing
Labeling
Compliance
Quality Assurance

学习目标

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

FDA’s New Final Rule for Electronic Drug Registration and Listing: What’s Changing? What’s Not?

概览

精选主题

谁应该参加？

学习目标

获得信息并保持参与