Advanced Certificate in Regulatory Affairs for CRAs
-- ViewingNowThe Advanced Certificate in Regulatory Affairs for Clinical Research Associates (CRAs) is a comprehensive course designed to provide learners with critical skills in regulatory affairs, a vital function in the clinical research industry. This certificate course emphasizes the importance of adhering to regulatory standards, ensuring the safety and rights of clinical trial participants, and driving successful study outcomes.
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Here are the essential units for an Advanced Certificate in Regulatory Affairs for Clinical Research Associates (CRAs):
• Regulatory Foundations and Compliance: An overview of global regulations, guidelines, and compliance requirements governing clinical trials, including ICH-GCP, FDA, and EMA regulations.
• Clinical Trial Design and Protocol Development: The design, development, and implementation of clinical trial protocols, including strategies for risk-based monitoring and quality assurance.
• Clinical Trial Applications and Approvals: The submission, review, and approval process for clinical trial applications, including INDs, IDEs, CTA, and NDA submissions.
• Clinical Trial Management and Operations: The management and oversight of clinical trial operations, including site selection, monitoring, data management, and safety reporting.
• Pharmacovigilance and Safety Reporting: The monitoring, assessment, and reporting of adverse events and product safety, including signal detection and risk management strategies.
• Regulatory Submissions and Lifecycle Management: The preparation, submission, and maintenance of regulatory submissions, including variations, renewals, and labeling changes.
• Quality Management and Auditing: The development and implementation of quality management systems and auditing strategies, including ISO 14155 and ISO 9001 standards.
• Regulatory Strategy and Product Lifecycle Planning: The development and execution of regulatory strategies and product lifecycle plans, including risk management and benefit-risk assessment.
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