Advanced Certificate Biosimilars for Regulatory Professionals
-- ViewingNowThe Advanced Certificate Biosimilars for Regulatory Professionals is a comprehensive course designed to meet the growing industry demand for experts in biosimilars. This certificate equips learners with critical skills necessary to navigate the complex regulatory landscape of bringing biosimilars to market.
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โข Introduction to Biosimilars: Definition, Concepts, and Rationale
โข Regulatory Framework for Biosimilars: Global Perspectives
โข Comparability Assessment: Analytical and Non-clinical Approaches
โข Clinical Development and Trials for Biosimilars
โข Pharmacovigilance and Risk Management Strategies for Biosimilars
โข Intellectual Property, Data Protection, and Regulatory Exclusivity
โข Labeling, Naming, and Prescribing Considerations for Biosimilars
โข Quality Management Systems and Good Manufacturing Practices
โข Regulatory Submissions and Approval Process for Biosimilars
โข Case Studies on Approved Biosimilars and Regulatory Challenges
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