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Session 8 Track 1: Lessons Learned from the AMCP Format
Session Chair(s)
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
Speaker(s)
Speaker
Katharine Coyle
IQVIA, United States
Senior Consultant, Real-World Insights, Health Economics/Outcomes Research
Speaker
Paul Petraro, DrSc, MPH
Boehringer Ingelheim Pharmaceuticals, Inc., United States
Global Head Real World Evidence