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EMA issues draft revisions of GVP Module V on Risk Managament Systems

FDA issues final guidance on Safety Fata Collection during Clinical Trials

MedDRA: English MedDRA Version 19.0 now available

France: on-going investigation of death case during Phase 1 CT


EMA launches PRIME – Paving the way for promising medicines for patients. New scheme supports European Commission priorities

The European Medicines Agency (EMA) launches its new PRIME (PRIority MEdicines) scheme to strengthen support to medicines that target an unmet medical need. The scheme focuses on medicines that may offer a major therapeutic advantage over existing treatments, or benefit patients with no treatment options. These medicines are considered priority medicines within the European Union (EU).