Description: This session will discuss best practices for preparing and interacting with the FDA as part of the Q-Sub meeting process. The session focuses specifically on FDA meeting interactions. Understanding how to structure your meeting request and prepare for the meeting will ensure that participants achieve the most from their interactions with the FDA. This session will cover best practices for preparing your meeting request, structuring of questions that you’re looking to get feedback on, understanding and assigning roles of meeting participants, hosting of the FDA meeting, and capturing the feedback from a documentation perspective.
Presentation 1:"Q-Sub content to obtain actionable feedback from FDA” John van Hove
Presentation 2: “How to prepare and host an effective Q-Sub meeting with FDA” John Lockwood
Participants will have an understanding of the best practices related to requesting and conducting FDA meetings
Participants will learn how to utilize FDA guidance on sponsor meetings