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Monday, June 28 • 4:00pm - 5:00pm
#154 SL: How Can We Compliantly Exchange Pre-Approval Information with Payers

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Component Type: Session
Level: Basic
CE: ACPE 1.00 Knowledge UAN: 0286-0000-21-558-L04-P; CME 1.00; IACET 1.00; RN 1.00

Discuss the practical challenges with interpretation aspects of the FDA Payer guidance released in 2018 for pre-approval communications and and possible operationalization considerations.

Learning Objectives

Describe how we can proactively and compliantly communicate during pre-approval phase relevant coverage and reimbursement information from industry to payers for population-based coverage decisions.


Sissi Pham, PharmD


Industry Perspective
Stephen Shinall, PhD

Industry Update
Susan A Cantrell, RPh

Industry Update
Lucy Rose, MBA

avatar for Sissi Pham

Sissi Pham

Chief Executive Officer, AESARA, United States
Sissi Pham is a founder and CEO of AESARA, Inc. and AESARA Foundation, both established in 2016. AESARA, Inc. was established with the commitment to absorb the administrative cost of the AESARA Foundation to enable the charity to give 100% of the donations to directly to humanitarian... Read More →

Stephen Shinall

Associate Director, Regulatory Affairs, US Advertising and Promotion, AbbVie, Inc., United States
avatar for Susan Cantrell

Susan Cantrell

Chief Executive Officer, Academy of Managed Care Pharmacy (AMCP), United States
Susan A. Cantrell, RPh, CAE Academy of Managed Care Pharmacy Susan Cantrell is Chief Executive Officer of AMCP, the professional association leading the way to help patients get the medications they need at a cost they can afford. AMCP’s diverse membership of pharmacists, physicians... Read More →
avatar for Lucy Rose

Lucy Rose

President, Lucy Rose and Associates, LLC, United States
Lucy graduated as a physician assistant, earned an MBA, and worked for seven years in sales and sales training with Bristol-Myers Squibb prior to serving as the Director of the Division of Drug Marketing, Advertising, and Communications and the Office of Training and Communications... Read More →

Monday June 28, 2021 4:00pm - 5:00pm EDT
TBD Virtual Event Horsham, PA 19044
  12: Value-Access, Session
  • Beginner Intermediate
  • Credit Type ACPE, CME, IACET, RN
  • Student Programming Regulator Thinking
  • Tags Session