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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)
Universal Usability Principles in Drug Delivery Device Labeling
Anthony D. Andre, PhD
Interface Analysis Associates, United States
Founding Principal
Challenges and Opportunities with Global UDI Implementation
Roshana Ahmed, MA, RAC
MAPI, Canada
Senior Manager, Regulatory Affairs, Medical Devices
Use of Social Media for Product Promotion: FDA and Company Coordination Issues to Consider
Alan G. Minsk, JD
Arnall Golden Gregory LLP, United States
Partner, Head of Food and Drug Team
Panelist
Gerrit Nijveldt, MSc
Opus Regulatory Inc., United States
Global Labeling Consultant
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