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

On Demand Recording

This Solution Provider Webinar is brought to you by DIA in cooperation with Reed Tech.

In this webinar...

This session will provide an overview of the FDA’s 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.

Learning Objectives

  • 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

Presenters

  • John Lorenc, Sr. Product Manager, Life Sciences, Reed Tech
  • Jonathan Nolan, Assoc. Product Manager, Life Sciences, Reed Tech
  • Gerrit Nijveldt, MSc, Sr. Director Regulatory Labeling, Sanofi