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Case Studies in Resolving Quality Issues
Session Chair(s)
Milind Ganjawala, MBA, MS
Supervisory Consumer Safety Officer, OMQ, OC, CDER
FDA, United States
Getting a drug approved is challenging, but it is even harder when the drug developer or manufacturer is inexperienced with regulatory agencies, the process following an inspection, and expectations from regulatory authorities. This session presents specific examples of how to recover from unsuccessful inspections and/or complete response action.
Learning Objective : Obtain an understanding of challenges encountered when manufacturing sites are inexperienced with ICH/GMP requirements; An overview of issues that arise when time pressure to meet corporate submission milestones does not allow for preparation of a complete dossier that meets requirements for multiple jurisdictions; Recommendations on efficient preparation of global CMC dossiers will be outlined.
Speaker(s)
Preparing Global CMC Dossiers when Faced with Challenging Corporate Milestones and Manufacturers Inexperienced with ICH/GMP
Duu-Gong Wu, DrSc, PhD
PPD, United States
Senior Director, Global Regulatory Affairs
A Small US Drug Manufacturing Company’s Journey from Complete Response to NDA Approval
Daniel Bollag, PhD
Ocular Therapeutics, United States
Chief Strategy Officer
Regulatory Perspective on Remediation of Inspectional Observations from an Application Viewpoint
Derek Smith, PhD
FDA, United States
Director, Div of Inspectional Assessment, OPF, OPQ, CDER
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