Certificate Biosimilars in Emerging Biopharma
-- ViewingNowThe Certificate Biosimilars in Emerging Biopharma course is a comprehensive program designed to meet the increasing industry demand for professionals with expertise in biosimilars. This course emphasizes the importance of biosimilars in the biopharma industry, focusing on the development, regulation, and commercialization of these products.
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⢠Introduction to Biosimilars: Defining biosimilars, their importance, and the difference between biosimilars and generic drugs.
⢠Biopharmaceutical Development: Overview of biopharmaceutical development, including bioprocessing, formulation, and analytics.
⢠Regulatory Affairs for Biosimilars: Regulatory pathways and guidelines for biosimilar approval in major markets.
⢠Clinical Development of Biosimilars: Designing and conducting clinical trials for biosimilars, including pharmacokinetics, pharmacodynamics, and immunogenicity studies.
⢠Comparability Studies: Principles and practices for comparability studies between biosimilars and reference products.
⢠Manufacturing and Quality Control: cGMP manufacturing, quality control strategies, and risk management in biosimilar production.
⢠Intellectual Property and Market Access: Intellectual property considerations, market access strategies, and pricing challenges in biosimilars.
⢠Stakeholder Engagement and Commercialization: Stakeholder management, marketing, and commercialization strategies for biosimilars in emerging biopharma.
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