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This is Your Pilot Speaking: The Journey from Regulatory Pilot Program Innovation to Routine Practice
Session Chair(s)
Andrew Emmett, MPH
Vice President, Global Regulatory Policy and Global Intelligence , Pfizer, United States
This panel will explore the blue skies of global regulatory pilot programs, including initiatives on real-world evidence (RWE), model-informed drug development (MIDD), innovative trials, and endpoints. Panelists will educate the audience on new opportunities and best practices for future pilot success.
Learning Objective : Critique new opportunities to participate in regulatory pilot programs at FDA and globally; Outline key lessons learned from pilot program case studies and experiences; Identify best practices to increase the likelihood of success for future pilot programs.
Speaker(s)
Moderator
Senior Director, US Head Regulatory Policy and Intelligence, Johnson & Johnson, United States
PDUFA VII Rare Disease Endpoint Advancement Program
Science Policy Analyst, ORDPURM, OND, CDER, FDA, United States
Learnings from FDA PDUFA VII Advancing Real-World Evidence Program
Lead Mathematical Statistician, OB, OTS, CDER, FDA, United States
Industry Update
Senior Vice President & Head, Global Regulatory Sciences, Pfizer Inc, United States
Industry Update
Head, US Regulatory Policy, Genentech, A Member of the Roche Group, United States
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