Certificate Biosimilar Development: Accelerated Pathways
-- ViewingNowThe Certificate Biosimilar Development: Accelerated Pathways course is a comprehensive program designed to equip learners with the essential skills needed for a successful career in the rapidly growing field of biosimilars. This course is of paramount importance as the biosimilar market is projected to reach $60 billion by 2030, creating a high demand for professionals who understand the complexities of biosimilar development.
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โข Introduction to Biosimilars: Defining biosimilars, their importance, and the differences between biosimilars and generic drugs.
โข Regulatory Landscape: Overview of regulations and guidelines for biosimilar development in major markets (e.g., FDA, EMA).
โข Biosimilar Development Process: Comparative analytics, non-clinical and clinical studies, and demonstrating biosimilarity.
โข Manufacturing and Quality Control: Current Good Manufacturing Practices (cGMP), analytical methods, and process validation.
โข Pharmacovigilance and Risk Management: Pharmacovigilance planning, risk management strategies, and safety monitoring.
โข Intellectual Property and Market Access: Understanding patents, data exclusivity, and navigating market competition.
โข Communication and Stakeholder Engagement: Communicating the value of biosimilars to healthcare providers, patients, and payers.
โข Case Studies in Biosimilar Development: Real-world examples of successful biosimilar development and commercialization.
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