Global Certificate in Biosimilar Development Economics
-- ViewingNowThe Global Certificate in Biosimilar Development Economics is a comprehensive course designed to meet the growing industry demand for professionals with expertise in biosimilars. This certificate program focuses on the economic, regulatory, and scientific aspects of biosimilar development, providing learners with a deep understanding of the biosimilar market and its impact on healthcare systems worldwide.
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⢠Introduction to Biosimilars: Definition, history, and importance
⢠Biosimilar Development Process: Cell-line development, process development, analytical methods
⢠Regulatory Affairs: Regulatory pathways, guidelines, and requirements
⢠Clinical Trials: Design, conduct, and analysis
⢠Intellectual Property: Patents, data exclusivity, and licensing
⢠Market Access and Pricing: Reimbursement, pricing strategies, and market dynamics
⢠Health Technology Assessment: HTA processes, outcomes, and impact
⢠Stakeholder Engagement: Patient groups, healthcare professionals, and policy makers
⢠Risk Management: Pharmacovigilance, safety monitoring, and risk minimization
⢠Global Harmonization: International guidelines, collaboration, and best practices
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