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Hot Topics in Medical Devices Labeling: US and Global

Track:
Regulatory Affairs and Submissions

Day & Time:
June 19, 9:00AM - 10:30AM (Pacific Standard Time)

Session Number:
406

Room Number:
2

Level:
Basic

Type:
Forum

Title:
Hot Topics in Medical Devices Labeling: US and Global

Chair(s):
Eileen S. Kahn, MEd, MS
Principal Labeling Associate
Sanofi US, United States

Description:
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(s):
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).

Presentation(s) & Speaker(s):
Universal Usability Principles in Drug Delivery Device Labeling
Anthony D. Andre, PhD
Founding Principal
Interface Analysis Associates, United States

Challenges and Opportunities with Global UDI Implementation
Roshana Ahmed, MA, RAC
Senior Manager, Regulatory Affairs
Optum, Canada

Use of Social Media for Product Promotion: FDA and Company Coordination Issues to Consider
Alan G. Minsk, JD
Partner
Arnall Golden Gregory LLP, United States

Panelist
Gerrit Nijveldt, MSc
Senior Director, Global Regulatory Affairs Labeling
Sanofi US , United States