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News dal mondo

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US internal Mock DEA-Style and Mirror Inspections and Audits: Trust But Verify

Drug Enforcement Administration (“DEA”) diversion investigators conduct random, unannounced cyclic inspections of “non-practitioner” registrants (manufacturers, distributors, importers, exporters and narcotic treatment programs) about every three years.  Investigators also randomly inspect hospitals, pharmacies and practitioners.  With civil monetary penalties for violations of recordkeeping and reporting requirements adjusted for inflation up to $19,246 per violation, periodic mock DEA-style and mirror inspections and audits are more important for registrants than ever....[FDABlog]

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Pharma e AI, il punto con CPA Italy

L’Intelligenza Artificiale governa anche la ricerca e la produzione Pharma, attuale e del...

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New ICH Q1 guideline is ‘one-stop shop’ for stability testing

The new International Council for Harmonisation (ICH) Q1 draft guideline on stability testing of drug...

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EU: dibattito sulle regole della sicurezza chimica

All’evento organizzato dal gruppo ECR al Parlamento europeo, l’Agenzia europea per le sostanze...

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