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Streamlining Regulatory Frameworks for Complex Generic Development: Global E&L Harmonization
Session Chair(s)
Allison Radwick, PHD, RPH
Senior Regulatory and Policy Communications Manager
U.S. Pharmacopeia, United States
Examine evolving E&L regulatory guidance focusing on ICH harmonization efforts to support complex generic development through aligned risk management approaches and streamlined global regulatory frameworks.
Learning Objective : Evaluate current global regulatory frameworks for E&L assessment in complex generic products; Analyze risk-based approaches for leachable impurity control across different jurisdictions; Synthesize harmonization opportunities to streamline product development and regulatory submissions.
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