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Session 8: Patient Labeling: Global View Part Two
Session Chair(s)
Dora W Cohen, MSc
Director, Global Labeling, PRA HS, United States
Patient labeling in the US has been evolving for years. The FDA continues to work with stakeholders in developing a single, standardized Patient Medication Information (PMI) document to promote the safe and effective use of prescription medication. Innovations in Internet-driven technologies that target information to patients require additional guidance. FDA and industry experts will discuss regulations, guidances, any potential updates, and offer insights in how to best prepare patient labeling.
Speaker(s)
Morgan Walker, PharmD, MBA
Patient Labeling Reviewer, FDA, United States
Patient Labeling Information 2016 Update
Elisabeth Walther, JD, PharmD
Regulatory Counsel, FDA, United States
Patient Medication Information Update
Ann Robards, MS
Labeling Consultant, Eli Lilly and Company, United States
Patient Labeling Considerations for Mobile Medical Applications and Software
Tracy Rockney, JD
Co-Founder and Managing Partner, Onesource Regulatory, United States
US Patient Labeling: The Impact on Consumer Promotion and Communication Activities
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