Interactions with the FDA can be pivotal moments in a drug development program. While these instances can be intimidating, the right preparation across your team can reduce anxiety around dealing with regulatory bodies, turning them into constructive scientific discussions built around a shared goal of bringing safe and effective treatments to patients.

In this webinar, our experts will draw on regulatory and sponsor-side experience to share practical insights into preparing for productive FDA interactions, communicating effectively, and understanding the perspectives of those across the table. This session will also examine the role of FDA Advisory Committee meetings and what sponsors should consider when external experts join the regulatory conversation.

Key Topics

• Key considerations when preparing for FDA interactions
• Approaches to effective scientific discussions with FDA reviewers
• The importance of understanding the FDA’s scientific perspective
• Practical lessons from sponsor-side regulatory experience

Speakers

• Melissa Spann – VP, Innovative Statistics
• Xiting Yang – Senior Director, Innovative Statistics
• Nelia Padilla – VP, Strategic Consulting