{"article_url":"https://newsverum.com/fr/news/ema-prac-october-2026-pharmacovigilance-outcomes","block":{"description":{"ar":"أعداد التقييمات الشهرية استناداً إلى جدول الأعمال الأولي.","en":"Monthly assessment counts based on the draft agenda.","es":"Recuentos mensuales de evaluaciones según el proyecto de orden del día.","fr":"Nombre mensuel d’évaluations selon le projet d’ordre du jour.","tr":"Taslak gündeme dayalı aylık değerlendirme sayıları."},"id":"verified-indicators","items":[{"basis":"observed","label":{"ar":"إشارات السلامة","en":"Safety signals","es":"Señales de seguridad","fr":"Signaux de sécurité","tr":"Güvenlik sinyalleri"},"measure":{"aggregation":"flow","frequency":"monthly","geography":"european-union","id":"prac-safety-signals","periodRole":"announcement-date","unitCode":"count"},"period":"2026-10","unit":"count","value":9},{"basis":"observed","label":{"ar":"التقييمات المنفردة لتقارير PSUR","en":"PSUR single assessments","es":"Evaluaciones únicas de PSUR","fr":"Évaluations uniques de PSUR","tr":"PSUR tekil değerlendirmeleri"},"measure":{"aggregation":"flow","frequency":"monthly","geography":"european-union","id":"prac-psur-single-assessments","periodRole":"announcement-date","unitCode":"count"},"period":"2026-10","unit":"count","value":85},{"basis":"observed","label":{"ar":"خطط إدارة مخاطر الأدوية المرخصة مركزياً","en":"Risk-management plans for centrally authorised medicines","es":"Planes de riesgos de medicamentos centralizados","fr":"Plans de gestion des risques des médicaments centralisés","tr":"Merkezi ruhsatlı ilaçlar için risk yönetim planları"},"measure":{"aggregation":"flow","frequency":"monthly","geography":"european-union","id":"prac-central-risk-plans","periodRole":"announcement-date","unitCode":"count"},"period":"2026-10","unit":"count","value":49},{"basis":"observed","label":{"ar":"دراسات السلامة بعد الترخيص","en":"Post-authorisation safety studies","es":"Estudios de seguridad posteriores a la autorización","fr":"Études de sécurité post-autorisation","tr":"Ruhsat sonrası güvenlilik çalışmaları"},"measure":{"aggregation":"flow","frequency":"monthly","geography":"european-union","id":"prac-post-authorisation-safety-studies","periodRole":"announcement-date","unitCode":"count"},"period":"2026-10","unit":"count","value":16},{"basis":"observed","label":{"ar":"إجراءات الإحالة التي بدأت أو استمرت أو اختُتمت","en":"Referrals started, ongoing or concluded","es":"Remisiones iniciadas, en curso o concluidas","fr":"Saisines commencées, en cours ou conclues","tr":"Başlatılan, süren veya sonuçlanan sevk prosedürleri"},"measure":{"aggregation":"flow","frequency":"monthly","geography":"european-union","id":"prac-referral-procedures","periodRole":"announcement-date","unitCode":"count"},"period":"2026-10","unit":"count","value":0}],"methodology":{"ar":"إشارة السلامة ليست دليلاً على السببية؛ وجميع الأعداد مبنية على جدول الأعمال الأولي.","en":"A safety signal is not proof of causation; all counts are based on the draft agenda.","es":"Una señal de seguridad no prueba causalidad; todos los recuentos se basan en el proyecto del orden del día.","fr":"Un signal de sécurité ne prouve pas la causalité ; tous les chiffres reposent sur le projet d’ordre du jour.","tr":"Güvenlik sinyali nedensellik kanıtı değildir; tüm sayılar taslak gündem temellidir."},"sourceUrls":["https://www.ema.europa.eu/en/news/meeting-highlights-pharmacovigilance-risk-assessment-committee-prac-28-september-1-october"],"title":{"ar":"إحصاءات لجنة PRAC في أكتوبر","en":"PRAC October statistics","es":"Estadísticas de octubre del PRAC","fr":"Statistiques d’octobre du PRAC","tr":"PRAC ekim istatistikleri"},"type":"metrics","updatedAt":"2026-10-04T03:00:27+03:00"},"version":1}