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Boston Convention and Exhibition Center

23 jun 2013 8:30 a.m. - 27 jun 2013 12:45 p.m.

415 Summer Street, , Boston, MA 02210 , USA

DIA 2013 49th Annual Meeting: Advancing Therapeutic Innovation and Regulatory Science

Session Chair(s)

Lynette  Hopkinson

Lynette Hopkinson

Vice President, Commercial Regulatory Affairs, Global Regulatory Affairs

Vertex Pharmaceuticals Incorporated, United States

Learning Objective : Discuss the regulatory history of patient labeling, particularly CMI and the collaborative efforts undertaken by the healthcare industry and FDA to explore ways to most effectively communicate the most useful prescription medication information to patients: Describe the design and objectives of two more recent pilot programs conducted with a one-page Patient Medical Information (PMI); Identify what patients expect from prescription medication information.

Speaker(s)

Julie  Aker, MT

Evaluation of Two Novel Formats Versus the Current CMI

Julie Aker, MT

Concentrics Research LLC, United States

President & CEO

Paul R. Wilson, MA

The PMI Operational Pilot Experience

Paul R. Wilson, MA

Catalina Health, United States

Vice President

Marc M. Boutin, JD

Patient Perspective: What Do Patients Want/Need?

Marc M. Boutin, JD

Novartis , Switzerland

Global Head of Patient Engagement and Advocacy

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