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Hot Topics in Medical Devices Labeling: US and Global
Session Chair(s)
Eileen Kahn, BSN, MSC
Sr. Manager, Global Regulatory Labeling, Consultant, United States
In this forum, we will address the use of device labeling regulations, guidelines, standards, and other labeling for reference. We will discuss the use of corporate labeling to create harmonized device labeling, as well as the implementation of these corporate labeling documents in specific countries.
Learning Objective : Describe how to create company core labeling for devices; Discuss the implementation process and tracking of core labeling changes; Discuss how to create optimal global patient labeling (comprehension studies).
Speaker(s)
Anthony D. Andre, PHD
Founding Principal, Interface Analysis Associates, United States
Universal Usability Principles in Drug Delivery Device Labeling
Roshana Ahmed, MA, RAC
Senior Manager, Regulatory Affairs, Medical Devices, MAPI, Canada
Challenges and Opportunities with Global UDI Implementation
Alan G. Minsk, JD
Partner, Head of Food and Drug Team, Arnall Golden Gregory LLP, United States
Use of Social Media for Product Promotion: FDA and Company Coordination Issues to Consider
Gerrit Nijveldt, MS, MSC
Global Labeling Consultant , Opus Regulatory, United States
Panelist
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