Claire Gelfman

Gain the critical insights needed to design toxicology programs that satisfy regulatory requirements while minimizing delays and costs. This collaborative workshop brings together toxicologists, regulatory experts, and preclinical specialists to help you navigate the complexities of safety assessment for novel ophthalmic delivery systems.

This workshop will gather experts to discuss:

• Master the selection of appropriate animal models (rabbits, non-human primates, mini pigs) and understand when each species provides the most predictive safety data for your specific formulation
• Learn how to structure GLP and non-GLP studies to de-risk your program, avoid costly FDA rejections, and determine the optimal timing for regulatory submission of your toxicology protocols
• Discover strategies to assess inflammation, immunogenicity, and ocular tissue damage for long-acting formulations, implants, and biologics while ensuring your safety package translates effectively to human trials