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Monday, June 28 • 1:00pm - 2:00pm
#122 SL: Market Access, Medical Affairs, and Regulatory Affairs Functions Working Together to Address Payor and Regulatory Requirements

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Component Type: Session
Level: Intermediate
CE: ACPE 1.00 Knowledge UAN: 0286-0000-21-533-L04-P; CME 1.00; IACET 1.00; RN 1.00

Drug development is evolving to address payor and regulatory requirements. Market access, medical affairs, and regulatory affairs functions are working together in this complex payor and regulatory ecosystem to sustain patient access to medicine.

Learning Objectives

Summarize how the market access, medical affairs, and Regulatory Affairs functions within a pharmaceutical company are working together differently now then they have in the past to address both payor and regulatory requirements; Name the ways the drug development is evolving to ensure clinical trials are addressing coverage and regulatory decisions.

Chair

Todd Paporello, PharmD, MBA

Speaker

Industry Perspective
I-Fen Chang, PharmD

Industry Perspective
Todd Paporello, PharmD, MBA

Industry Perspective
Cindy McDonald-Everett


Speakers
IC

I-Fen Chang

Vice President, Head of Oncology Global Medical, Amgen, United States
I-Fen Chang is the Vice President of Global Medical Therapeutic Area Head for Hematology/Oncology at Amgen. In this capacity, I-Fen is directly responsible for oversight of US and Global medical strategy, external engagement and evidence generation. I-Fen has over 17 years of experience... Read More →
avatar for Todd Paporello

Todd Paporello

Vice President, Global Head of Regulatory Affairs, Specialty Care, Sanofi, United States
Todd Paporello is the Vice President & Global Head of Regulatory Affairs Specialty Care at Sanofi. Before joining Sanofi, he held leadership positions of increasing responsibility within regulatory affairs at Bayer, Roche, Genentech, Merck, and Schering-Plough. Todd holds pharmacy... Read More →
avatar for Cindy McDonald-Everett

Cindy McDonald-Everett

Senior Vice President, Global Value Access, Seagen, United States
Cindy McDonald-Everett is Senior Vice President of Global Value Access at Seagen. She leads a team dedicated to demonstrating value to key stakeholders in the healthcare system to ensure patient access. She has extensive industry experience leading global market access and pricing... Read More →

Monday June 28, 2021 1:00pm - 2:00pm EDT
TBD Virtual Event Horsham, PA 19044
  09: Regulatory, Session |   04: MedAffairs-SciComm, Session |   12: Value-Access, Session
  • Beginner Intermediate
  • Credit Type ACPE, CME, IACET, RN
  • Student Programming Regulator Thinking,RWD-RWE
  • Tags Session