Global Certificate in Trial Regulatory Guidelines
-- ViewingNowThe Global Certificate in Trial Regulatory Guidelines is a comprehensive course designed to empower learners with the essential skills needed to navigate the complex world of trial regulatory compliance. This course is critical for professionals in pharmaceutical, biotech, and medical device industries where adherence to global regulations is paramount.
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• Global Trial Regulatory Guidelines Overview
• International Conference on Harmonisation (ICH)
• Good Clinical Practice (GCP) Guidelines
• Clinical Trial Protocol Development
• Investigational New Drug (IND) Application Process
• Ethics Committees and Institutional Review Boards (IRBs)
• Safety Reporting and Pharmacovigilance
• Data Management and Statistical Analysis in Clinical Trials
• Inspection, Quality Assurance, and Quality Control
• Post-Marketing Surveillance and Pharmacoepidemiology
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