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Session 7: Combination Product and Device Labeling
Session Chair(s)
Su-Yueh Lin
Sr. Labeling Consultant, Regulatory Affairs
SYL Regulatory Consulting, Taiwan
Gerrit Nijveldt, MSc
Global Labeling Consultant
Opus Regulatory Inc., United States
The labeling for drug-device combination products - drugs that are combined with device-based delivery systems - continues to evolve as a topic of interest for the industry. This session will discuss the current guidance and regulations for combination product labeling in the US and EU. Useful information on combination product labeling development from conceptualization to agency approval will be provided from industry and regulator perspectives. Some key elements of the medical device regulation (MDR) will also be presented as the May 2020 deadline for the implementation is approaching.
Learning Objective :
At the conclusion of this session, participants should be able to:
- Describe the latest information regarding the Human Factor Study in the US
- Describe the key recommendations and practical information in FDA’s draft guidance of Instructions for Use issues in July 2019
- Gain latest knowledge on the EU medical device regulation (MDR)
Speaker(s)
Labeling for (Drug-)Device Products and FDA Draft Guidance for Instruction for Use
Gerrit Nijveldt, MSc
Opus Regulatory Inc., United States
Global Labeling Consultant
Human Factors Engineering for Combination Products
Martin McLoughlin, PhD
Bristol-Myers Squibb, United States
Head of Device Development, Global Product Development and Supply
Speaker
Gina Monteiro
Eli Lilly and Company, United States
Advisor