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Session 8: Reacting to Market Feedback for Changes in Advanced Technology
Session Chair(s)
James Wabby, MHS
Global Head, Regulatory Affairs, Emerging Technologies and Combination Products
AbbVie, United States
Karthik Balasubramanian, PhD, MS
VIce President, CMC & Technical Operations
Verrica Pharmaceuticals, United States
This panel will discuss the impact of changing advanced technology (microneedles, on-body injectors, e-connected technology) on your combination product and its risk management file. Participants will be able to understand the key risks and mitigations for ensuring that advanced combination products can remain safe and effective through ongoing market feedback. Topics to be covered will include appropriate threshold setting, safety signals, and integrating with safety physicians.
Learning Objective : At the conclusion of this session, participants should be able to:
- Identify how market feedback changes advanced technology
- Create appropriate change thresholds for market feedback
- Identify key organizational stakeholders for integration
Speaker(s)
Speakers
Mark DeStefano
Teva Pharmaceuticals, United States
Director: Combination Products and Device R&D
Speaker
Tycho Speaker, PhD
Abbvie, United States
Director, Drug Delivery and Biomaterials
Speaker
Carolyn White, MS
Allergan/AbbVie , United States
Executive Director, R&D Quality