Global Certificate in Combination Product Regulatory Affairs
-- ViewingNowThe Global Certificate in Combination Product Regulatory Affairs is a comprehensive course designed to meet the growing industry demand for experts in this field. Combination products, which consist of a drug, device, or biologic, require a unique regulatory approach.
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โข Introduction to Combination Products
โข Regulatory Framework for Combination Products
โข Global Combination Product Categories
โข Combination Product Classification and Jurisdictional Determination
โข Quality Systems and GMP Considerations for Combination Products
โข Combination Product Labeling, Packaging, and Tracking Requirements
โข Clinical Trials and Post-Market Surveillance for Combination Products
โข Combination Product Data Management and Submission Strategies
โข Pharmacovigilance and Adverse Event Reporting for Combination Products
โข Case Studies and Best Practices in Combination Product Regulatory Affairs
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- BasicUnderstandingSubject
- ProficiencyEnglish
- ComputerInternetAccess
- BasicComputerSkills
- DedicationCompleteCourse
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- NotAccreditedRecognized
- NotRegulatedAuthorized
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- ThreeFourHoursPerWeek
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