Global Certificate in Clinical Trial Regulatory Practices
-- ViewingNowThe Global Certificate in Clinical Trial Regulatory Practices is a comprehensive course designed to meet the growing industry demand for professionals with expert knowledge in clinical trial regulations. This certificate program emphasizes the importance of understanding and navigating the complex regulatory landscape to ensure compliance and successful clinical trials.
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โข Introduction to Clinical Trials: Understanding the basics of clinical trials, their purpose, and the different phases
โข Global Regulatory Landscape: Overview of global regulatory bodies and their role in clinical trial oversight
โข International Conference on Harmonisation (ICH): Examining ICH guidelines and their impact on clinical trial regulatory practices
โข Good Clinical Practice (GCP): Comprehension of ICH-GCP principles and their implications for clinical trial conduct
โข Ethical Considerations: Investigating ethical guidelines, informed consent, and subject protection
โข Investigational New Drug (IND): Application process, requirements, and amendments for INDs in the United States
โข Clinical Trial Applications (CTAs): Exploring the CTA submission, review, and approval processes in the European Union
โข Clinical Trial Authorisation (CTA): Application, assessment, and approval processes for clinical trials in other regions (e.g. Japan, China, etc.)
โข Pharmacovigilance and Safety Reporting: Monitoring, assessing, and reporting adverse events and safety data throughout clinical trials
โข Data Management and Quality Assurance: Ensuring data integrity, accuracy, and compliance with regulatory standards
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