Preclinical testing is far more than a regulatory requirement—it is the foundation upon which regulatory decisions are built. Yet many development teams approach preclinical studies as a series of individual milestones rather than as part of a broader evidence generation strategy. The result can be unnecessary studies, avoidable delays, increased costs, or additional questions during regulatory review.

In this webinar, Endpoint’s regulatory and medical device strategy expert, Dr. Sam Gilbert, VMD  will share a practical framework for planning and executing preclinical programs with the end goal in mind. Through real-world examples and lessons learned across a wide range of device programs, attendees will explore how to develop a regulatory roadmap, select appropriate studies, engage effectively with regulatory agencies, and build the evidence needed to support successful submissions.

Whether you are preparing your first preclinical program or refining an established development strategy, this session will provide practical guidance for navigating the path from concept to approval.

Key Learning Objectives:

• Understand the general and product-specific regulatory considerations that influence preclinical testing strategies.
• Discover a practical roadmap for planning and executing a preclinical regulatory strategy.
• Explore approaches for engaging with regulatory agencies to help reduce development risk before and after preclinical testing.
• Examine real-world case studies that highlight common regulatory challenges, deficiencies, and successful outcomes.
• Identify best practices for developing preclinical evidence that supports successful regulatory submissions.