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Under expert medical guidance, BPC-157 is considered to have a strong safety profile

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The European contribution of this review lies primarily in the regulatory analysismapping the interplay of the EU AI Act, MDR, and GDPR for quality management applicationsand in the proposed implementation framework, which was derived through author consensus informed by GAMP 5 principles, EU AI Act risk categorization, and professional experience at three German academic medical centers rather than through empirical pilot data or formal expert elicitation methods such as Delphi

Boekhoorn K, Joels M, Lucassen PJ

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