EMA Compassionate Use

Learn the fundamentals of EMA Compassionate Use in this concise regulatory training module. This video breaks down Article 83 of Regulation (EC) No 726/2004, eligibility criteria, Member State responsibilities, CHMP recommendations, and the full process for cohort‑based access to unauthorised medicines. Perfect for regulatory affairs professionals, clinical operations teams, and anyone working with EU access pathways for investigational products. What you’ll learn: What Compassionate Use is and when it applies Legal basis under Article 83 Eligibility criteria for cohort‑based access Roles of EMA, CHMP, and Member States How Compassionate Use differs from named‑patient access Transparency and reporting requirements