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Streamlining Regulatory Frameworks for Complex Generic Development: Global Extractables and Leachables Harmonization
Session Chair(s)
Allison Radwick
Senior Regulatory and Policy Communications Manager
U.S. Pharmacopeia, United States
Examine evolving extractables and leachables (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.
Speaker(s)
Panelist
Chaitanya Koduri, DDS, MHS
US Pharmacopeia, United States
Director, International Government and Regulatory Engagement
Panelist
Karthik Balasubramanian, PHD, MS
Teva Pharmaceuticals, United States
Dir Project/Program Management, External Manufacturing
Panelist
James Wabby, MHS
AbbVie, United States
Global Head, Regulatory Affairs, Emerging Technologies and Combination Products
Panelist
Ji Guo, PHD
FDA, United States
Chemist, OPQ, CDER
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