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25 YEARS SCRATCH-Lecture Series- Part 2: From AI Possibility to GxP Practice: Practical AI Applications in Pharmacovigilance
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25 YEARS SCRATCH-Lecture Series- Part 2: From AI Possibility to GxP Practice: Practical AI Applications in Pharmacovigilance
Lecturer: Dr. Julia Appelskog, Head of QPPV Office, Stockholm
- The evolving regulatory landscape: What EMA, FDA, MHRA, the EU AI Act and CIOMS guidance mean for the use of AI in pharmaceutical operations.
- AI governance and compliance: Risk-based validation, human oversight, accountability, vendor management and inspection readiness.
- Practical AI applications in pharmacovigilance: ICSR processing, literature monitoring, signal detection, aggregate reporting and safety data analysis.
- AI in Quality Management: Regulatory intelligence, dossier preparation, document management, deviations, CAPA, audits and PSMF maintenance.
- From experimentation to implementation: Practical AI tools, Microsoft Copilot, automation opportunities and how to introduce AI responsibly into daily workflows
Termin
6. November 2026
Uhrzeit
12:00 – 13:00 Uhr
Ort
Online
Preis
125,00 € netto / Person
Plätze
100 von 100 verfügbar
Format
Online · Englisch
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- Daten der Teilnehmenden
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