UK Clinical Trial Regulations and MHRA Compliance
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30 Modules
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Live Executive Programs
Accreditation Earned:
UK Clinical Trial Regulations and MHRA Compliance
This program will provide you with valuable insights into the UK’s clinical trial regulations, enabling effective management and compliance across all phases of trial design, initiation, conduct, and closeout.
Key skills you will gain:
- UK Clinical Trial Regulation 2004
- Human Medicines Regulation 2012
- MHRA Compliance
- GCP Principles Application
- Informed Consent Management
- HRA/REC Ethics Submissions
- CTA Submission Process
- Sponsor Oversight Planning
- Vendor Management
- Trial Master File (TMF) Management
- Corrective and Preventive Actions (CAPA)
- MHRA Inspection Readiness
- Risk-Based Monitoring (RBM)
- Data Integrity ALCOA+
- Adverse Event Reporting
- GDPR-Compliant Data Handling
- Protocol Compliance Management
- Cross-Border Trial Governance
- Real-World Evidence Integration
- Decentralized Trial Execution
- AI-Enabled Trial Design
- Quality Management Systems (QMS)
- Documentation Standards
- Trial Closeout Procedures
- Stakeholder Communication
- Multi-Site Trial Coordination
- Ethical Risk Mitigation
- Participant Diversity Planning
- Regulatory Risk Assessment
- Post-Brexit Regulatory Navigation