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Session 8: Combination Products and Medical Device Labeling and Closing Remarks
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
This session will discuss the current guidance and regulations for combination product labeling in the US and EU. Useful information on combination product and medical device labeling development from conceptualization to agency approval will be provided with perspectives from industry and regulator.
Learning Objective : At the conclusion of this session, participants should be able to:
- Describe the latest information regarding the current regulations and guidance for combination product and medical device labeling in the US and EU
- Identify best practices when developing labeling (e.g., instructions for use) for a drug-device combination product
- Discuss the latest updates on the EU’s medical device regulation (MDR)
Speaker(s)
Human Factors and Labeling: Considerations for Design and Marketing Submissions
Jason Flint, MBA, PMP
FDA, United States
Associate Director for Human Factors Reviewer, CDER, OSE, OMERPM, DMEPA
Device Labeling
Gerrit Nijveldt, MSc
Opus Regulatory Inc., United States
Global Labeling Consultant
Speaker
Karthik Balasubramanian, PhD, MS
Verrica Pharmaceuticals, United States
VIce President, CMC & Technical Operations
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