戻る Agenda
Labeling and Patient Medical Information (PMI)
Session Chair(s)
Lynette Hopkinson
Vice President, Commercial Regulatory Affairs, Global Regulatory Affairs
Vertex Pharmaceuticals Incorporated, United States
Currently three documents serve to communicate patient product information, the Patient Package Insert (PPI), Medication Guide, and Consumer Medication Information (CMI). None are deemed optimal as a ‘One Document Solution’. Over the past 20 years FDA has collaborated with multiple healthcare stakeholders to explore how to effectively communicate the most useful prescription medication information to patients. This session will discuss two pilot projects that were conducted with one-page Patient Medical Information (PMI) samples to determine, amongst other objectives, patient comprehension and patient preferences for format, content and method of receipt.
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)
Evaluation of Two Novel Formats Versus the Current CMI
Julie Aker, MT
Concentrics Research LLC, United States
President & CEO
The PMI Operational Pilot Experience
Paul R. Wilson, MA
Catalina Health, United States
Vice President
Patient Perspective: What Do Patients Want/Need?
Marc M. Boutin, JD
Novartis , Switzerland
Global Head of Patient Engagement and Advocacy