Koźmiński Zdrowie

1. Foundations of Clinical Trials    - Drug development phases, trial types, pediatric and non-commercial trials 2. Legal & Ethical Frameworks    - GCP, GMP, GLP, GDPR, EU CTR, ethics committee procedures 3. Project & Site Management    - Feasibility, budgeting, contracting, communication skills 4. Patient-Centered Research & Pharmacovigilance    - Recruitment, retention, clinical pharmacology, adverse event reporting 5. Quality & Compliance    - Documentation standards, audits and inspections, risk of fraud 6. Data Management & AI    - Data systems, AI-supported monitoring, innovations in clinical tech 7. Trial Operations    - CRA role, monitoring strategy, site visit execution, remote work protocols 8. Capstone Project    - Collaborative project with real-case analysis and defense