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Session 3: Labeling for Combination Products and Devices
Session Chair(s)
Su-Yueh Lin
Sr. Labeling Consultant, Regulatory Affairs
SYL Regulatory Consulting, Taiwan
Discuss regulatory and labeling requirements for the increasing number of drugs that are combined with device-based delivery systems, or drug-device combination products. Human Factor Studies (HFS) provide key information to describe the safe and effective use of the device component, and are also important in plans for labeling of combination products in development. This session will describe the process for the Human Factor Study (HFS) and the associated draft guidances from FDA and MHRA.
Speaker(s)
Human Factors Engineering
Valerie Fenster
Amgen Inc., United States
Senior Manager, Human Factors Engineering, Device Technologies
Labeling for a Combined Medicinal Product or Medical Device
Tara D Baer
PRA Health Science, United States
Executive Director, Global Labeling