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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⢠Introduction to Biosimilars: Definition, Concepts, and Rationale
⢠Regulatory Framework for Biosimilars: Global Perspectives
⢠Comparability Assessment: Analytical and Non-clinical Approaches
⢠Clinical Development and Trials for Biosimilars
⢠Pharmacovigilance and Risk Management Strategies for Biosimilars
⢠Intellectual Property, Data Protection, and Regulatory Exclusivity
⢠Labeling, Naming, and Prescribing Considerations for Biosimilars
⢠Quality Management Systems and Good Manufacturing Practices
⢠Regulatory Submissions and Approval Process for Biosimilars
⢠Case Studies on Approved Biosimilars and Regulatory Challenges
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