The Q-submission program is a gift to industry from the FDA yet it is misunderstood and wholly underused. Be the leader that introduces a Q-submission program to your organization. In the Solution Circle we will explore the benefits of the Q-sub, development strategies, and building a relationship with FDA with the mutual goal of bringing a safe and effective product to market.
Learning Objectives:
Understand the types of Q-subs and circumstances in which to use this tool.
Describe at least three solid reasons a Q-Submission will benefit their organization.
Understand and employ the tools needed to collaborate with FDA with the mutual goal of bringing a safe and effective product to market.