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


Mar 22, 2021 9:50 AM - Mar 24, 2021 2:30 PM

(Eastern Standard Time)

Medical Affairs and Scientific Communications Forum

Session 8 Track 1: Lessons Learned from the AMCP Format

Session Chair(s)

Peter  Mollegard, MA

Peter Mollegard, MA

Senior Director, Business Development, Contract Sales & Medical Solutions

IQVIA, United States

In December 2019, the AMCP Format Executive Committee released Format 4.1 after years of assessing how to address the information needs to support pre-approval assessments and budgeting. This important update process included a public comment period during which time stakeholders from the manufacturer, payer, academia, consultancy, and professional association perspectives submitted comments, along with input from the FDA. This Hot Topic session will leave participants with an understanding of the needs behind the recommended updates, and a working knowledge of the differences between 4.0 and 4.1.

Learning Objective :
  • Discuss the reasoning behind the AMCP decision to update format 4.0 to 4.1, as opportunities for further improvement
  • Recognize the differences between formats 4.0 and 4.1 in the preparation of product dossiers, including the addition of available real-world evidence (RWE) and comparative effectiveness research (CER)
  • Plan for the completion of an unapproved product or unapproved use dossier as well as a full AMCP dossier using the 4.1 guidance


Katharine  Coyle


Katharine Coyle

IQVIA, United States

Senior Consultant, Real-World Insights, Health Economics/Outcomes Research

Paul  Petraro, DrSc, MPH


Paul Petraro, DrSc, MPH

Boehringer Ingelheim Pharmaceuticals, Inc., United States

Global Head Real World Evidence

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.