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2022 ISPE Annual Meeting & Expo

NA22CEOCT1/SES110 - Concurrent Session: Combination Products - Evolving State of the Art

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


Concurrent Session: Combination Products - Evolving State of the Art | 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.


  • Boaz Eitan, PhD, Founder, Chairman and CTO, Eitan Medical
  • Steven Hertz, MBA, PE, Consumer Safety Officer, Office of Pharmaceutical Quality, CDER/FDA
  • Susan W. Neadle, FAAO, FBCLA, President, Combination Products Consulting Services LLC

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