Certified EU Good Clinical Practice Manager (CGCP™)
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66 Modules
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Live Executive Programs
Professional Designation Earned: CGCP™
This certified program will equip you with expertise in GCP compliance within EU, enabling you to lead ethical, high-quality clinical trials.
Key skills you will gain:
- GCP Compliance
- ICH E6(R3) Implementation
- EU CTR 536/2014 Compliance
- Ethical Clinical Research Conduct
- Risk–Benefit Assessment
- GDPR & Participant Privacy
- Ethics Committee Oversight
- Investigator Site Management
- Sponsor Oversight
- CRO Management
- Trial Master File (TMF) Administration
- Risk-Based Quality Management (RBQM)
- Quality-by-Design (QbD) in Clinical Trials
- Protocol Development & Review
- Statistical Analysis Planning
- Data Integrity (ALCOA+)
- Electronic Data Capture (EDC/eCRF)
- Investigational Medicinal Product (IMP) Management
- Good Manufacturing Practice (GMP) Compliance
- Pharmacovigilance Reporting
- Adverse Event (AE/SAE/SUSAR) Management
- Audit & Inspection Readiness
- Corrective & Preventive Action (CAPA)
- Continuous Quality Improvement
- CTIS Submission & Transparency
- Clinical Study Report (CSR) Preparation
- Post-Trial Obligations Management
- Decentralized & Hybrid Trials (DCTs)
- Real-World Data (RWD) & Evidence (RWE) Integration
- Ethical Leadership in Clinical Research