The field of generic ophthalmic drug products is rapidly evolving, with increasing complexity in drug product formulations and devices, leading to challenges in assessing performance sameness and ensuring quality. In response to these evolving complexities, this workshop is designed to address the latest advancements and regulatory challenges in the field, offering a unique platform to engage with all relevant parties, share knowledge, and contribute to the evolution of generic development and regulatory assessment.
Attendees will gain valuable insights into the intricacies of developing ophthalmic products, including insertable, implantable, and topical ophthalmic therapies. In addition to a series of expert-led presentations and panel discussions, in-person attendees will interact directly with regulators, industrial peers, and academic experts in small group working sessions to deepen their understanding of current practices and challenges, regulatory expectations, and emerging trends.
Specifically, the workshop will cover critical issues such as in vitro drug release testing, qualitative (Q1) and quantitative (Q2) sameness of polymers in ophthalmic products, formulation characterization, considerations for clinical bioequivalence studies, and the challenges encountered when developing or assessing prospective generic ophthalmic products.
For more information about these events, as well as other FDA and CRCG collaborative activities, visit http://www.complexgenerics.org/.