Masterclass Certificate in Biopharma Trials Management
-- ViewingNowThe Masterclass Certificate in Biopharma Trials Management is a comprehensive course designed to provide learners with critical skills in managing biopharma clinical trials. This certificate program emphasizes the importance of rigorous trial management, ensuring data integrity, and compliance with regulatory standards.
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GBP £ 140
GBP £ 202
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โข Biopharma Regulations and Compliance: Understanding FDA and EMA regulations, ICH guidelines, and GxP compliance in biopharma trials
โข Clinical Trial Design and Protocol Development: Designing phase I-IV clinical trials, writing clinical trial protocols, and implementing adaptive designs
โข Site Selection, Feasibility, and Initiation: Identifying and selecting suitable trial sites, conducting feasibility assessments, and initiating clinical trial sites
โข Budgeting, Contracting, and Financial Management: Developing budgets, negotiating contracts, and managing financial aspects of biopharma trials
โข Project Management and Monitoring: Implementing project management principles, monitoring trial progress, and using project management tools
โข Data Management and Biostatistics: Managing clinical trial data, applying biostatistical methods, and utilizing electronic data capture (EDC) systems
โข Quality Assurance, Quality Control, and Auditing: Ensuring quality in biopharma trials, implementing quality control measures, and conducting internal and external audits
โข Ethics and Patient Safety in Clinical Trials: Ensuring ethical conduct, protecting patient safety, and adhering to international ethical guidelines
โข Regulatory Submissions and Post-Marketing Surveillance: Preparing and submitting regulatory documents, and managing post-marketing surveillance and pharmacovigilance
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