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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โข Introduction to Biosimilars: Definition, history, and importance
โข Biosimilar Development Process: Cell-line development, process development, analytical methods
โข Regulatory Affairs: Regulatory pathways, guidelines, and requirements
โข Clinical Trials: Design, conduct, and analysis
โข Intellectual Property: Patents, data exclusivity, and licensing
โข Market Access and Pricing: Reimbursement, pricing strategies, and market dynamics
โข Health Technology Assessment: HTA processes, outcomes, and impact
โข Stakeholder Engagement: Patient groups, healthcare professionals, and policy makers
โข Risk Management: Pharmacovigilance, safety monitoring, and risk minimization
โข Global Harmonization: International guidelines, collaboration, and best practices
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