Long-Acting Injectable (LAI) Generics: Advancing Innovation in Product Development and Regulatory Assessment Date and Time: December 1 , 8:00 am – 5:05 pm , December 2 , 8:00 am – 4:30 p

https://www.complexgenerics.org/education-training/long-acting-injectable-lai-generics-advancing-innovation-in-product-development-and-regulatory-assessment/?utm_medium=email&utm_source=govdelivery Are you looking to deepen your understanding of regulatory science, bioequivalence strategies, and quality considerations for complex long-acting injectable (LAI) drug products? This 2-day hybrid workshop brings together FDA, industry, and academic experts to address the most pressing scientific and regulatory challenges in generic LAI product development. The program will include a series of expert-led presentations and interactive discussions to examine current challenges and consider emerging solutions relating to generic LAI product development and regulatory assessment, including: Formulation and excipient characterization strategies Drug release mechanisms and in vitro release testing (IVRT) Totality of evidence frameworks Innovative pharmacokinetic (PK) study designs Model-integrated evidence to support product development Regulatory expectations for complex LAI ANDA submissions Common abbreviated new drug application (ANDA) deficiencies and strategies to address them VIRTUAL ATTENDANCE: Attend all presentations and panel discussions Participate in all Q&A panel discussions by submitting questions online in real time to the speakers and panelists Enjoy free access to workshop recordings of presentations and panel discussions (excluding the in-person-only sessions) IN-PERSON ATTENDANCE: In-person attendees will enjoy all the benefits of virtual attendance and, additionally, interact directly with experts from FDA, academia, industry, consulting groups, and others to deepen their understanding of current practices and challenges, regulatory expectations, and emerging trends. These high-engagement scientific interactions will be facilitated through two in-person-only sessions: A session dedicated to informal networking and candid dialogue with FDA, industry, academic, and other subject matter experts about scientific and regulatory challenges for complex LAI products. A guided session for small groups of in-person attendees including real-world case studies and consensus mapping to identify priorities and actionable outcomes by working through challenging issues for LAI formulation and excipient characterization, IVRT method development, bioequivalence approaches, and model-integrated evidence strategies. The in-person component will take place at The Universities at Shady Grove, Rockville, MD. Don’t miss this opportunity to advance your expertise, network with leading professionals, and help shape the future of LAI generics. For more information, please visit https://www.complexgenerics.org/education-training/long-acting-injectable-lai-generics-navigating-technical-hurdles-in-product-development-and-regulatory-assessment/ .