Advanced Certificate Biosimilars in Cell & Gene Therapy
-- ViewingNowThe Advanced Certificate Biosimilars in Cell & Gene Therapy course is a comprehensive program designed to equip learners with the essential skills required in the rapidly growing field of biosimilars and cell & gene therapy. This course emphasizes the importance of understanding the scientific, regulatory, and commercial aspects of bringing biosimilars and cell & gene therapy products to market.
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โข Introduction to Biosimilars: Understanding the basics of biosimilars, their development, and regulatory requirements.
โข Cell & Gene Therapy Fundamentals: Overview of cell and gene therapy technologies, mechanisms, and applications.
โข Biosimilars Manufacturing Process: Detailed exploration of the manufacturing process for biosimilars, including upstream and downstream operations.
โข Comparability Studies in Biosimilars: Examining the role of comparability studies in demonstrating biosimilarity to the reference product.
โข Clinical Development & Trials: Exploring the clinical development and trial strategies for biosimilars in cell and gene therapy.
โข Regulatory Affairs & Guidelines: Review of global regulatory guidelines and requirements for biosimilars in cell and gene therapy.
โข Quality Assurance & Control: Understanding the principles of quality assurance and control in the development, production, and testing of biosimilars.
โข Intellectual Property & Commercialization: Overview of intellectual property considerations and commercialization strategies for biosimilars in cell and gene therapy.
โข Risk Management & Pharmacovigilance: Discussing risk management and pharmacovigilance strategies to ensure patient safety and product quality.
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