Already a DIA Member? Sign in. Not a member? Join.

Sign in

Forgot User ID? or Forgot Password?

Not a Member?

Create Account and Join

Virtual Event

Apr 20, 2020 7:45 AM - Apr 21, 2020 2:45 PM

(US Eastern Standard Time)

Fort Washington, PA 19034

Global Labeling Conference

Session 2: Tracking and Compliance

Session Chair(s)

Theresa  Brunone, MLS, MS

Theresa Brunone, MLS, MS

Head-Labelling Compliance and Implementation, Global Labeling

GlaxoSmithKline, United States

Paula  Hudson, RPh, RAC

Paula Hudson, RPh, RAC

Director, Global Labeling

Eli Lilly and Company, United States

End to end tracking of labeling submissions is a pharmacovigilance activity [tracking from signal identification/validation through regulatory submission/approval and finally through the creation of production packaging artwork and product distribution] and a source of many potential areas for opportunities for miscommunications and delays to product availability in the hands of the patients. A wide variety of solutions exist across the pharmaceutical, biologics, and device industries. We will look at what is implemented in various companies for governance and tracking, and where the pain points are for future improvements in tracking and labeling compliance.

Learning Objective :

At the conclusion of this session, participants should be able to:

  • Identify milestones commonly used in end-to-end labeling tracking and compliance
  • Define deviations including types, use, and value of capturing
  • Discuss the types of regulatory complicane metrics, when each may be effective, and considerations for selection for use

Speaker(s)

David  Gwyn, MBA

Connected Labeling: The Final Frontier in Content Management

David Gwyn, MBA

fme US, United States

VP, Business Consulting Services

Nya  Feldthus, MS

Labeling Tracking

Nya Feldthus, MS

Eli Lilly and Company, Denmark

Associate Director - Gobal Labeling Implementation

Shannon  Leber, MBA

Timely Implementation Monitoring

Shannon Leber, MBA

Janssen Pharmaceuticals, United States

Associate Director, GRA Quality & Compliance

Kathleen  Salazar, MA, MBA

Timely Implementation Monitoring

Kathleen Salazar, MA, MBA

Johnson & Johnson Innovative Medicine, United States

Head, Global Labeling Implementation

Have an account?

Be informed and stay engaged.

Don't miss an opportunity - join our mailing list to stay up to date on DIA insights and events.