Certified EU Clinical Trials Project Manager (CCT™)
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62 Modules
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Live Executive Programs
Accreditation Earned: CCT™
This certified program will equip you with advanced project management skills to navigate EU regulatory frameworks, deliver compliant multi-national trials & accelerate innovative therapies across Europe.
Key skills you will gain:
- EU Clinical Trial Regulation (CTR) Compliance
- CTIS Portal Navigation
- Clinical Trial Application (CTA) Preparation
- Ethics Committee Submissions
- EMA & NCA Coordination
- Safety Reporting and Pharmacovigilance
- Clinical Trial Management System (CTMS)
- Good Clinical Practice (GCP) Standards
- Trial Protocol Development
- Patient Recruitment & Retention Strategies
- Patient Participation
- Informed Consent Processes
- Vulnerable Population Safeguards
- GDPR & Data Confidentiality
- MedTech Device Trials and Artificial Intelligence
- Pharmacovigilance Systems
- EudraVigilance Reporting
- Adverse Event (AE) Management
- Development Safety Update Reports (DSURs)
- Investigational Medicinal Product (IMP) Management
- ATMP Regulatory Pathways
- Supply Chain & Traceability
- Budgeting & Contract Negotiation
- Cross-Border Trial Coordination
- Audit & CAPA Planning
- Trial Close-Out & Archiving
- Risk-Based Quality Management
- Multi-National Trial Coordination
- Centralized & On-Site Monitoring
- Clinical Data Integrity