Advanced Certificate in Biotech Clinical Trials Management
-- ViewingNowThe Advanced Certificate in Biotech Clinical Trials Management is a comprehensive course designed to equip learners with the necessary skills to thrive in the rapidly growing biotechnology industry. This program emphasizes the importance of clinical trials management, a critical aspect of biotech drug development.
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โข Biotech Clinical Trials Regulation: Understanding FDA, EMA, and ICH guidelines
โข Clinical Trial Design and Protocol Development: Phases, endpoints, and study populations
โข Good Clinical Practice (GCP): International ethical and scientific quality standard for designing, conducting, recording, and reporting trials
โข Biostatistics: Data analysis, hypothesis testing, and sample size calculation
โข Clinical Data Management: Electronic Data Capture (EDC), CRFs, and data validation
โข Pharmacovigilance: Adverse event reporting, safety monitoring, and risk management
โข Budgeting and Contract Management: Financial planning, negotiation, and compliance
โข Project Management: Timelines, milestones, and resource allocation
โข Quality Assurance and Quality Control: Audits, inspections, and corrective actions
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