2025 ACCP Virtual Journal Club Webinar: Driving Efficiency: Leveraging Model-Informed Approaches in 505(b)(2) Regulatory Actions - ON DEMAND

Live Session: Tuesday, June 10^th, 2025, from 12:00 to 1:00 PM ET

On Demand: June 10^th, 2025 to June 10^th, 2028

Why is this webinar important to your practice? 

This webinar will explore how model-informed drug development (MIDD) techniques are being used to support regulatory approval of new products through the 505(b)(2) pathway. Through detailed case studies, learners will gain practical insight into how the US Food & Drug Administration has accepted model-based justifications for dosing, safety and efficacy, using examples involving fixed-dose combinations, high-potency opioid antagonists and dose optimization in renal or hepatic impairment. Learners that complete this event will understand the significance of model-informed approaches in drug development and regulatory decisions associated with 505(b)(2) submissions.

Target Audience:

Interprofessional team of Physicians, Pharmacists, PhDs and other healthcare professionals interested in the application of MIDD in regulatory applications.

Learning Objectives

After completing this activity, the learner will be able to:

• Describe applications of model-informed approaches that have been utilized to provide evidence of effectiveness;
• Explain how model-informed approaches have been applied to optimize dosing in patient subgroups;
• Explain how a model-informed approach has been used to inform policy.