Track 2, Session 3
Iris Tam, PharmD
Iris Tam, PharmD, FAMCP, is Vice President & Head of Medical Affairs and HEOR at Coeus Consulting Group with over 30 years of experience in health care, including hospital pharmacy, managed care pharmacy, and the pharmaceutical industry. In her combined 17 years at large and start-up biopharmaceutical companies, she designed and led Medical Affairs strategies and tactics that specifically support market access, product value, and patient quality of care, including accountabilities for medical communications, health economics and outcomes research, product dossiers, compendia submissions, guideline bodies engagement, and scientific interactions and communications with payers and other healthcare entities who make policy, coverage, formulary, and reimbursement decisions. From 2008 to 2021, Dr. Tam served on the Academy of Managed Care Pharmacy (AMCP) Format Executive Committee which oversees the AMCP Format for Formulary Submissions, including serving as the Committee’s Chair for 3 years.
This presentation will provide an overview of the AMCP Format for Formulary Submissions—the guidelines for developing the AMCP product dossier—including the background on why these were started in 2000. We will review the basic components of a product dossier (content, structure, format) and identify some key considerations for medical writers to ensure the delivery of a well-written dossier. Understanding what is accurate, relevant, and user-friendly for the applicable audience, as well as understanding the purpose of the dossier, will help the medical writer be aware of common pitfalls often occurring in the real world.