Executive Development Programme in Biosimilar Safety & Effectiveness
-- ViewingNowThe Executive Development Programme in Biosimilar Safety & Effectiveness is a certificate course designed to address the growing demand for expertise in the biosimilar industry. This programme emphasizes the importance of biosimilars in healthcare, focusing on their safety and effectiveness.
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โข Introduction to Biosimilars: Defining biosimilars, their importance, and the regulatory framework
โข Biosimilar Development: Understanding the development process, including research, clinical trials, and approval
โข Comparability Studies: The role of comparability studies in biosimilar development and safety assessment
โข Biosimilar Manufacturing: Key aspects of biosimilar manufacturing, including quality control and assurance
โข Pharmacovigilance: Monitoring biosimilar safety in the post-marketing phase, including adverse event reporting and risk management
โข Immunogenicity: Understanding immunogenicity and its impact on biosimilar safety and effectiveness
โข Interchangeability: Exploring the concept of interchangeability and its implications for biosimilar use
โข Regulatory Affairs: Navigating the regulatory landscape for biosimilars, including global regulations and guidelines
โข Effectiveness and Cost-effectiveness: Evaluating the effectiveness and cost-effectiveness of biosimilars compared to reference biologics
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