Advanced Certificate in Pharma Clinical Trial Compliance
-- ViewingNowThe Advanced Certificate in Pharma Clinical Trial Compliance is a comprehensive course designed to meet the growing industry demand for professionals with expertise in clinical trial compliance. This certificate program emphasizes the importance of adhering to regulations and standards, ensuring the safety and efficacy of new pharmaceutical products.
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โข Regulatory Framework for Clinical Trials: Understanding ICH-GCP, FDA regulations, and EU directives
โข Clinical Trial Design and Protocol Development: Adaptive, parallel, crossover, and factorial designs
โข Ethics in Clinical Trials: Informed consent, patient privacy, and data security
โข Quality Management in Clinical Trials: Implementing and maintaining QMS, ISO 14155
โข Clinical Trial Monitoring: Site selection, initiation, close-out, and remote monitoring
โข Data Management in Clinical Trials: EDC systems, CDISC standards, and data validation
โข Statistical Analysis in Clinical Trials: Intention-to-treat, per-protocol, and interim analyses
โข Pharmacovigilance and Safety Reporting: AE, SA, SAE, and SUSAR reporting
โข Clinical Trial Audits and Inspections: Preparing for and managing regulatory inspections
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