News dal mondo
27
Apr
US QMM: Participants scored well on commitment to quality, lower on advanced manufacturing
Pharmaceutical companies participating in the US Food and Drug Administration (FDA) Quality Maturity Pilot (QMM) program generally received high scores for their commitment to quality and employee engagement, but scored lower in areas related to advanced pharmaceutical quality and technical excellence. Eric Twum, a regulatory specialist for the Division of Quality II in the Office of Quality Surveillance (OQS) within the Office of Pharmaceutical Quality (OPQ) in the Center for Drug Evaluation and Research (CDER), shared these insights on the QMM pilot at the Generic Drugs Forum held online and in White Oak, MD, on 22 April....[RAPS]
22
Mag
Min. Salute - Strategia nazionale sulla salute e sicurezza sul lavoro, approvata in Conferenza Stato-Regioni
La Conferenza Stato-Regioni ha approvato il 21 maggio 2026, tramite accordo formale, la Strategia nazionale...
22
Mag
Testo unico farmaceutica, i lavori entrano nel vivo: a breve l’esame dei 302 emendamenti
...L’iter del provvedimento è ormai prossimo a entrare finalmente nel vivo, con l’esame...
18
Mag
AIFA Sistema informatico Workflow Officine Materie Prime - Ulteriore Aggiornamento tecnico 18 maggio 2026
Formati files ammessi: PDF editabile o p7m. Scansioni a 200 dpi, anche in bianco e nero, per ottimizzare...
15
Mag
US FDA’s New AI-Informed Inspection Pilot and What It Means for Industry
We have written on this blog about FDA’s modernization agenda from several angles lately—from...
le ultime news
22 Mag
Min. Salute - Strategia nazionale sulla salute e sicurezza sul lavoro, approvata in Conferenza Stato-Regioni
22 Mag
Testo unico farmaceutica, i lavori entrano nel vivo: a breve l’esame dei 302 emendamenti
18 Mag
AIFA Sistema informatico Workflow Officine Materie Prime - Ulteriore Aggiornamento tecnico 18 maggio 2026
15 Mag
US FDA’s New AI-Informed Inspection Pilot and What It Means for Industry
15 Mag
EU Regulators discuss new pharma legislation, AI, and more
15 Mag
US FDA official details top observations from QMSR inspections
15 Mag
European Commission outlines plans to mobilize EMA to diversify supply chains
13 Mag
Deal on tackling EU shortages of essential medicines