Modules

Module 1: Fundamentals of Clinical Trial Compliance

• Overview of Good Clinical Practice (GCP) and ICH guidelines.
• Key regulatory bodies: FDA, EMA, WHO, MHRA.
• Hands-on Exercise: Identifying compliance risks in clinical trials.

Module 2: Regulatory Submissions and Approvals

• IND, NDA, and BLA applications.
• Institutional Review Board (IRB) and Ethics Committee (EC) approval process.
• Hands-on Exercise: Preparing a regulatory submission checklist.

Module 3: Risk-Based Monitoring and Audit Readiness

• Implementing risk-based monitoring (RBM) strategies.
• Preparing for regulatory inspections and audits.
• Hands-on Exercise: Conducting a mock clinical trial audit.

Module 4: Quality Assurance in Clinical Trials

• Developing clinical quality management systems (CQMS).
• Managing protocol deviations and corrective actions.
• Hands-on Exercise: Writing a Corrective and Preventive Action (CAPA) plan.

Module 5: Ethical Considerations and Future Trends

• Ethical challenges in clinical trials.
• Digital transformation and AI in clinical research compliance.
• Hands-on Exercise: Drafting an ethical compliance policy.