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Brief
Document Overview The inspection conducted by the French National Agency for Medicine and Health Products Safety (ANSM) at CERAVER from December 13 to 15, 2023, revealed significant non-conformities and shortcomings in the company's research activities. The ANSM issued an injunction letter on February 15, 2024, citing multiple breaches of regulations, including insufficient human resources for supervision and vigilance, inadequate documentation management, and unreported serious adverse events. Key Findings and Compliance Considerations The inspection highlighted several critical issues, including the absence of a valid and secure electronic observation journal, imperfections in the research protocol, and non-compliance with data protection regulations. The ANSM has mandated CERAVER to address these deficiencies within specified deadlines, emphasizing the importance of implementing compliant systems for vigilance, documentation management, and patient data protection.
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