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2022 ISPE Annual Meeting & Expo

SES110 - Concurrent Session: Combination Products


Oct 31, 2022 1:45pm ‐ Oct 31, 2022 3:15pm


Description

Growing expectations for state-of-the-art innovation in the combination product space continue to evolve around the world. Shifts in regulatory frameworks, guidance, control strategies and technical product solutions are making substantive impacts on the delivery of new medicinal therapies. Yet, efforts to drive convergence are in their infancy. This session will discuss a range of key shifts in the expectations, practices and state-of-the-art technology solutions, including the QSR Amendment proposed rule, the Genus v. FDA court decision, Essential Performance Requirements, Combination Products Human Factors and Risk Management, EU MDR, and Harmonization Efforts underway. Case studies will be presented, reflecting the impacts of these evolving expectations on combination products.

Speaker(s):

  • Susan W. Neadle, FAAO, FBCLA, President, Combination Products Consulting Services LLC

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