Global Certificate in Biopharma Product Development Lifecycle Management
-- ViewingNowThe Global Certificate in Biopharma Product Development Lifecycle Management is a comprehensive course designed to provide learners with a deep understanding of the entire biopharma product development lifecycle. This course is crucial for professionals looking to advance their careers in the biopharma industry, as it covers essential skills in product development, regulatory affairs, clinical trials, and market approval.
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⢠Introduction to Biopharma Product Development Lifecycle Management: Understanding the regulatory landscape, key stakeholders, and the drug development process
⢠Target Product Profile (TPP) Development: Defining product attributes, clinical endpoints, and patient population
⢠Preclinical Development: Animal studies, toxicology assessment, and IND-enabling studies
⢠Clinical Development Phases I-IV: Designing, conducting, and analyzing clinical trials
⢠Biostatistics and Data Management: Data collection, analysis, and interpretation in clinical trials
⢠Regulatory Affairs and Submissions: Interacting with regulatory authorities, preparing regulatory submissions
⢠Quality Assurance and Control: Ensuring product quality, compliance, and continuous improvement
⢠Manufacturing and Supply Chain Management: Scale-up, production, and distribution in compliance with regulatory standards
⢠Pharmacovigilance: Monitoring, assessing, and managing drug safety and risk management plans
⢠Post-Marketing Surveillance: Monitoring and reporting adverse events, lifecycle management strategies
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