Advancing Bioequivalence Frameworks for Inhalation and Nasal Drug Products: Optimizing In Vitro, In Vivo, and In Silico Methods

14th October 2026 - 15th October 2026, Maryland, USA or Online

Join us at Advancing Bioequivalence Frameworks for Inhalation and Nasal Drug Products: Optimizing In Vitro, In Vivo, and In Silico Methods, taking place from 14–15 October 2026.

Hosted as a hybrid workshop, with opportunities to participate either in person in Maryland, US or remotely, the event will provide a valuable forum for industry experts, scientists and regulators to discuss the continued evolution of bioequivalence approaches for locally acting inhalation and nasal drug products.

Co-hosted by the FDA and the Center for Research on Complex Generics, this two-day workshop will bring together industry experts, scientists and regulators to explore the continued evolution of bioequivalence approaches for locally acting inhalation and nasal drug products.

The workshop will focus on the transition towards option-based bioequivalence frameworks and the growing role of innovative in vitro, in vivo and in silico methods as alternatives to comparative clinical endpoint bioequivalence studies. Through expert-led discussion, the event will explore how advanced methodologies can support more efficient generic product development, optimise study design, reduce redundancies and enhance evaluation efficiency.

Our CEO, Jamie Clayton, will be attending as a panelist, sharing his expert perspective on the practical application of in vitro testing approaches and their role in supporting the development and evaluation of inhalation and nasal drug products. Drawing on his extensive experience in OINDP testing, Jamie will contribute insight into the analytical, regulatory and workflow considerations that are shaping the future of bioequivalence assessment in this specialist area.

Whether you are working on inhaled or nasal product development, comparative testing, regulatory submissions or laboratory workflow optimisation, we would be pleased to connect with you during the event.

Contact us in advance at [email protected] to arrange a meeting with a member of the Copley team.

Register your interest by completing the form below, and we will notify you when registration opens.

 

Advancing Bioequivalence Frameworks for Inhalation and Nasal Drug Products Interest Form

 

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