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Operationalizing Adaptive Design for FDA's One-Trial Era
Operationalizing Adaptive Design for FDA's One-Trial Era
October 20, 2026 : 11:00 AM ET
On February 18, 2026, the FDA...
Drug developers hire regulatory consultants and CROs to help navigate the complex regulatory agency requirements and interactions throughout the development lifecycle. While most Sponsors understand the role of a Regulatory Strategist, fewer have familiarity with the responsibilities and importance of a Regulatory Project Manager (PM). A Regulatory Strategist plays the principal role during the pre-IND stage and the Project Manager steps into the primary role once the IND planning and preparation begins.
Listen to the full episode on Veristat’s Advancing Revolutionary Therapies Podcast to learn more about the invaluable contributions and responsibilities of a Regulatory Project Manager.
Learning Points
- Key responsibilities of a Regulatory Project
- Manager Importance of leveraging a Regulatory Project Manager at a CRO
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