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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)
Patient Labeling Information 2016 Update
Morgan Walker, PharmD, MBA
FDA, United States
Patient Labeling Reviewer
Patient Medication Information Update
Elisabeth Walther, JD, PharmD
FDA, United States
Regulatory Counsel
Patient Labeling Considerations for Mobile Medical Applications and Software
Ann Robards, MS
Eli Lilly and Company, United States
Labeling Consultant
US Patient Labeling: The Impact on Consumer Promotion and Communication Activities
Tracy Rockney, JD
Onesource Regulatory, United States
Co-Founder and Managing Partner
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