This two-day workshop covers advances in bioequivalence frameworks for locally acting inhalation drug products. It targets industry professionals, academics, and regulators to discuss optimizing in vitro and in vivo methods for generic inhalation products. Attendees will gain understanding of current methods, regulatory expectations, and novel approaches to support efficient generic drug development and approval.
Advances 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 s
This event explores how to write effective prompts to get better results with less effort. It is designed for anyone interested in improving prompt writing, possibly targeting software engineers or AI practitioners. Attendees can learn practical strategies to be more efficient in prompt creation.
This event features a demo or presentation followed by networking time for participants to share ideas and projects related to electronics and robotics. It is designed for makers of all experience levels interested in aged and malfunctioning computers. Attendees can seek help advancing their work in a collaborative environment at the Rockville Makerspace.
This series features monthly fireside chats with tech professionals sharing their career paths and advice. It is aimed at individuals interested in exploring technology careers and gaining insights from experienced speakers. Attendees gain valuable perspectives on career development and strategies for navigating the tech industry.
This in-person bootcamp teaches adults how to design mobile apps for Apple devices without coding. Participants will create app prototypes using Apple Keynote and present their projects at the end. It is intended for anyone interested in learning app design fundamentals and prototyping skills.
This workshop explores the scientific, regulatory, and technical aspects of developing generic GLP-1 products. It is designed for regulatory scientists, industry professionals, and researchers involved in drug development. Attendees will gain knowledge about regulatory pathways, manufacturing, formulation, and device integration for generic GLP-1 drugs.
This event features a short demo or presentation followed by time for participants to share projects, ideas, and challenges. It is designed for makers and hobbyists of all experience levels who want to collaborate and progress in electronics and robotics. Attendees benefit from peer support and practical interaction in a community space.