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Session 5A: Business Track - Integrating Regulatory Intelligence to Create a “Differentiating” Target Product Profile
Session Chair(s)
Shanthi Sethuraman, PhD
Director, Regulatory Center of Excellence, Global Regulatory Affairs-US
Eli Lilly and Company, United States
The Target Product Profile (TPP) is an FDA-recommended prescription drug product development tool. This is a powerful tool that can drive the development of the regulatory strategy and facilitate interactions with regulatory authorities and key stakeholders. Using this tool for internal project team interactions can help gain cross-functional alignment of clinical plans with desired/anticipated labeling claims and promotional messages throughout the drug development process. Leveraging regulatory intelligence is a critical imperative to the regulatory professional to differentiate a product based on approved drug labeling and promotional messages. The opportunities and challenges to integrate the right type and amount of regulatory information at the right times during drug development will be discussed during this session.
Speaker(s)
Beginning with the End in Mind – Post-Approval Learnings Focused on the Premarket Period
Tracy Rockney, JD
Onesource Regulatory, United States
Co-Founder and Managing Partner
Leveraging Regulatory Intelligence to Drive Insightful Target Product Profiles
Robin Wojcieszek, RPh
Eli Lilly & Company, United States
Senior Director, Global Regulatory Affairs-US
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