Certified EU Clinical Trial Safety and Pharmacovigilance Manager (CTS™)
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60 Modules
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Live Executive Programs
Professional Designation Earned: Certified EU Clinical Trial Safety and Pharmacovigilance Manager (CTS™)
Master EU clinical trial safety, SAE/SUSAR reporting, EudraVigilance, CTIS, benefit-risk assessment, and PV governance to strengthen patient safety and inspection readiness.
Key skills you will gain:
- EU CTR 536/2014 Regulatory Compliance
- Good Clinical Practice (GCP) Compliance
- Good Pharmacovigilance Practice (GVP) Compliance
- Clinical Trial Safety Governance
- Clinical Trial Sponsor Safety Oversight
- Adverse Event (AE) Assessment
- Serious Adverse Event (SAE) Management
- SUSAR Identification and Reporting
- Expedited Safety Reporting Compliance
- Urgent Safety Measures (USM) Management
- EudraVigilance SUSAR Reporting
- Individual Case Safety Report (ICSR) Management
- E2B(R3) Electronic Safety Reporting
- MedDRA Coding and Terminology
- Safety Data Quality Management
- Reference Safety Information (RSI) Assessment
- DSUR Preparation and CTIS Annual Safety Reporting
- Pharmacovigilance Signal Detection
- Signal Validation and Evaluation
- Benefit-Risk Assessment
- Risk Management Plan (RMP) Development
- Safety Risk Minimization
- QPPV Governance and Oversight
- Pharmacovigilance System Master File (PSMF) Management
- Clinical Safety Data Reconciliation
- CRO and Pharmacovigilance Vendor Oversight
- Pharmacovigilance Quality Management Systems
- Root-Cause Analysis and CAPA Management
- Pharmacovigilance Audit and Inspection Readiness
- CTIS Safety Notifications and Regulatory Compliance