Anders Vidstrup

The new Annex 22 on AI from EMA: End User POV

AI can—when applied responsibly and for business purposes—create significant value for companies. But where do we draw the line in a highly regulated environment, where rules and compliance define the boundaries?

In this presentation, Anders Vidstrup will review the new proposal from the European Medicines Agency regarding the use of AI in GMP environments. The focus will be on regulatory expectations as well as the key interfaces that determine when AI solutions can be used—and when they should not be used—in a compliance-critical setup.

Bio:
Anders Vidstrup is a Senior Specialist at the Capital Region Pharmacy, Sterile Production. He works with quality and compliance aspects of production facilities, equipment, and computer systems, and has extensive experience with requirements specification, design reviews, construction, quality assurance, commissioning, and qualification.

With more than 25 years of experience in the pharmaceutical industry, he has worked broadly with qualification and validation in roles as Quality Responsible and specialist. He is a co-author of GAMP 5 and related guidance documents, leads the Cloud Adoption Group under FDA/PhUSE, and participates in Danish and international DS/ISO committees on health informatics and artificial intelligence.