Regulatory bodies like the FDA are signaling support for New Approach Methodologies, yet clear guidance on model validation and qualification remains elusive. This workshop explores what data regulators expect for validated models and how leading biopharma can achieve confidence in model validation. Gain clarity on validation versus qualification

and uncover strategies to align with regulatory expectations for successful IND submissions.

• Understanding how biopharma validates and qualify models to secure FDA acceptance and ensure models answer critical research questions
• Gaining clarity on validation versus qualification to prioritize the right process for research goals
• Identifying what validation data and metrics FDA expects to improve clarity for in vitro model application and leadership buy-in
• Exploring ways to make reference data accessible to help regulators provide actionable guidance for biopharma