Veridat reposted this
Experienced Clinical GCP auditor (Internal, ISA, PV, TMF, and Vendor) with experience in quality management role (R&D, Clinical Quality, Quality Compliance) in support of clinical trials.
I’ve been part of several conversations about AI in clinical trials over the past week. Take a look John Giantsidis summary.
Pharmaceutical and biologics adoption of #artificialintelligence just received another #regulatory boost. European Medicines Agency spells out that any such adoption shall meet EU #AIACT, data protection (including #GDPR), #cybersecurity (including the #CRA), and #NIS2. It is advisable for any AI/ML use case, whether submitted to #FDA or #EMA, would need to have evidence of: • Human oversight • Technical robustness, security and safety • Privacy and data governance • Transparency • Accountability • Societal and environmental well-being • Diversity and fairness. Veridat, CyberActa, SynapCon - Faster Clinical Trials (SaaS) AI & ML-based platform for Medtech, Biotech and Pharma are here from drug discovery and development to pharmacovigilance and clinical studies. 🚨 https://lnkd.in/eY3DgFg9 for more details.