Clinical Pharmacology Considerations for Radiolabeled Mass Balance Studies - Webinar
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15 days ago
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Defining the Value of Medical Affairs
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Market Access Advisory Panels
Payer Advisory Board Strategy
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Risk Management Evaluation
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Calibration & PM Programs
Deviation Investigations
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Facility Maintenance Programs
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3
Corrective Action Verification
Deviation Investigation
Quality Process Governance
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Batch Release Testing
Raw Material Testing
Stability Program Testing
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4
Compliance
5
Agency Meeting Support
Dossier & Application Development
eCTD Publishing & Validation
Pre-Submission Advisory Meetings
Regulatory Compliance
Labeling & Promotions
2
Core Data Sheet Management
Labeling Strategy Development
Maintenance & Renewals
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Post-Approval Safety Reporting
Promotional Material Compliance
Variations & Supplements
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Clinical Disclosure
Clinical Transparency
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FDA CDER Small Business and Industry Assistance (SBIA)
This webinar will discuss the final guidance for the industry Clinical Pharmacology Considerations for Human Radiolabeled Mass Balance Studies which was published in July 2024.
Our FDA subject matter experts will also address recommendations from the guidance including, deciding whether and when to conduct the study, as well as how to design and report results from a human radiolabeled mass balance study.
Earn 1.0 CME/CPE/CNE!
Register here ➡️ Clinical Pharmacology Considerations for Radiolabeled Mass Balance Studies - 11/12/2024 | FDA
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