# Event Details - **Event Name**: Advancing BE Frameworks for Inhalation Drug Products: Optimizing Methods - **Event Start and End Date**: Wed, 14 Oct, 2026 at 08:00 am – Thu, 15 Oct, 2026 at 05:30 am (-04:00) - **Event Description**: This workshop will address the latest BE methods and associated challenges shaping the development of complex generic inhalation products.About this EventAdvances in analytical methods and bioequivalence assessment science have driven the evolution of bioequivalence recommendations for locally acting inhalation products toward option-based bioequivalence frameworks, incorporating innovative in vitro, in vivo, and in silico methods as viable alternatives to comparative clinical endpoint studies. These developments represent meaningful opportunities to modernize and strengthen the development and approval of generic inhalation products. As with any emerging methodology, their novelty may give rise to questions where additional clarity could further support their implementation. This workshop will explore these opportunities with the goal of building shared understanding, refining best practices, reducing redundancies, and streamlining evaluations that will ultimately support more efficient generic development programs and timely approvals.Attendees will gain valuable insights into the current understanding, regulatory expectations, and industry experiences with developing, validating, and using in vitro and in vivo methods included as part of bioequivalence recommendations for metered dose inhalers (MDIs) and dry powder inhalers (DPIs) without significant formulation differences with their reference standard (RS). The final session of the workshop will explore the potential for using innovative in vitro and in vivo methods in these option-based frameworks with products containing significant formulation differences with their RS. In addition to a series of expert-led presentations and panel discussions, in-person attendees will interact directly with experts from industry, academia and regulatory agencies to better understand the current practices and considerations with conducting these studies.The two-day workshop is designed to discuss in vitro methods for particle size distribution, dissolution and particle morphology; the current expectations and potential alternatives to charcoal block in vivo pharmacokinetic studies; a look forward at opportunities to expand use of these bioequivalence approaches and areas for products with significant formulation differences from their RS.AgendaD1 S1: Current Bioequivalence Approaches for Inhalation Drug ProductsInfo: Presentations (in person and virtual): This session details the Agency’s latest advancements in bioequivalence (BE) strategies recommended for inhalation products, their associated challenges, and opportunities for clarity and efficiency. Topics include the current option-based framework, recommended BE studies, method considerations, industry experiences and challenges, and future directions for research initiatives and additional guidance. D1 S2: Revisiting Realistic Particle Size Distribution Study Designs/AnalysesInfo: Presentations and Panel Discussion (in person and virtual): This session examines the FDA expectations and industry experience with conducting conventional and realistic APSD studies. Speakers will cover topics such as selection and use of anatomical mouth-throat models and breathing profiles, approaches for statistical analyses, study size, capturing clinically relevant variability, bracketing approaches, and potential opportunities for addressing common challenges. D1 S3: Expectations for Designing Sensitive Dissolution MethodsInfo: Presentations and Panel Discussion (in person and virtual): This session examines the FDA expectations and industry experience with dissolution studies. Speakers will cover topics on the rationale and utility of dissolution for inhalation products, method development and sample collection, validation, demonstrating sensitivity, approaches for statistical analysis, and applicability of biopredictive and/or biorelevant approaches. D1 S4: Expectations and Opportunities with Particle Morphology TestingInfo: Presentations and Panel Discussion (in person and virtual): This session examines the FDA expectations and industry experience with particle morphology characterization studies. Speakers will cover topics on purpose of utility of particle morphology characterization across inhalation products, current and alternative methods for morphology characterization, and considerations and challenges with multi-component formulations.D1 S5: Open Exchange (in person only)Info: Interactive Discussions on Focused Product Development and Assessment Areas (in person only): This session is dedicated to interactive discussions and candid dialogue with FDA, Industry, Academic, and other subject matter experts about scientific and regulatory challenges for complex inhalation generic products. D2 S6: Small Group Working Session (in person only)Info: Interactive Working Session (in person only): In this collaborative session, participants will join small-group discussion tables facilitated by FDA, industry, and academic experts. In-person attendees will engage in guided discussions and exercises related to Sessions 2-4, building consensus, and reporting of actionable research or recommendations. The outcome of this session will be a meeting report summarizing key discussion points, consensus findings, and emerging recommendations, which will be shared publicly after the workshop.D2 S7: Waivers for In Vitro & In Vivo PK Studies– Challenges & OpportunitiesInfo: Presentations and Panel Discussion (in person and virtual): This session explores the considerations and challenges with the recommended in vivo PK BE studies, including more complex designs like charcoal-block studies. Speakers will cover topics related to the rationales for current recommendations, implications and experiences from industry, and where alternative methods like in silico modeling may have potential for improving efficiency.D2 S8: Moving Beyond Formulation SamenessInfo: Presentations and Panel Discussion (in person and virtual): The final hybrid session focuses on the implications of formulation sameness recommendations for inhalation products. Speakers will cover topics on the role of formulation sameness with inhalation products based on current scientific understanding, along with potential opportunities for moving beyond these recommendations through improved understanding of the critical factors governing product performance. - **Event URL**: https://allevents.in/rockville/advancing-be-frameworks-for-inhalation-drug-products-optimizing-methods/100001992447591381 - **Event Categories**: business, workshops, nonprofit, meetups, art, theatre - **Interested Audience**: - total_interested_count: 0 - **Event Highlights**: - door_time: 2026-10-14T11:15:00Z - Duration: 21 hours 30 minutes - Location: The Universities at Shady Grove - Languages: English ## Ticket Details - **Ticket Price Range**: min: 0, max: 350, currency: USD ## Event venue details - **city**: Rockville - **state**: MD - **country**: United States - **location**: The Universities at Shady Grove - **lat**: 39.0941938 - **long**: -77.2005936 - **full address**: The Universities at Shady Grove, 9630 Gudelsky Drive, Rockville, United States ## Event gallery - **Alt text**: Advancing BE Frameworks for Inhalation Drug Products: Optimizing Methods - **Image URL**: https://cdn-az.allevents.in/events9/banners/39fd949cc65a939e98e36568c70c8046dd316261548443c6813fc17e2970dc27-rimg-w1200-h600-dcdee7f9-gmir.jpg?v=1782359875 ## FAQs - **Q**: When and where is Advancing BE Frameworks for Inhalation Drug Products: Optimizing Methods being held? - **A:** Advancing BE Frameworks for Inhalation Drug Products: Optimizing Methods takes place on Wed, 14 Oct, 2026 at 08:00 am to Thu, 15 Oct, 2026 at 05:30 am at The Universities at Shady Grove, 9630 Gudelsky Drive, Rockville, United States. - **Q**: Who is organizing Advancing BE Frameworks for Inhalation Drug Products: Optimizing Methods? - **A:** Advancing BE Frameworks for Inhalation Drug Products: Optimizing Methods is organized by Center for Research on Complex Generics. - **Q**: Who is this event for? Is it right for me? - **A:** Advancing BE Frameworks for Inhalation Drug Products: Optimizing Methods is ideal for curious learners, students, and skill-builders looking to gain hands-on knowledge and practical expertise in a focused, interactive setting. Whether you're a first-time attendee or a longtime enthusiast in Rockville, this event is thoughtfully curated to deliver a standout experience worth every moment. 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