miércoles, 1 de octubre de 2025

Registration Now Open for FDA-CRCG Workshop: Visionary Standards: Advancing Science and Regulation in Generic Ophthalmic Products

https://www.eventbrite.com/e/visionary-standards-advancing-sci-reg-in-generic-ophthalmic-products-tickets-1591247968509?aff=oddtdtcreator&utm_medium=email&utm_source=govdelivery Are you looking to deepen your understanding of regulatory science, bioequivalence strategies, and quality considerations for complex ophthalmic drug products? This 2-day hybrid workshop brings together FDA, industry, and academic experts to address the latest scientific advancements and regulatory challenges shaping the development of generic ophthalmic products. Through a series of presentations and interactive discussions, participants will examine the complexities of achieving formulation sameness and handling compositional differences, delve into advanced in vitro testing strategies and modeling approaches, and explore bioequivalence solutions for ophthalmic dispersions, inserts, and implants. The program will also highlight critical quality and microbiological considerations and provide clarity on regulatory pathways for drug-device combination products, equipping attendees with the knowledge needed to navigate this rapidly evolving space. Choose your experience: In-person: Engage in collaborative discussion tables, connect directly with experts from industry, academia, and regulatory agencies, and participate in immersive working sessions. Virtual: Access expert presentations and panel discussions from anywhere. https://www.complexgenerics.org/education-training/visionary-standards-advancing-science-and-regulation-in-generic-ophthalmic-products/?utm_medium=email&utm_source=govdelivery

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