Flex Databases invites you to their event

AI in eTMF: Autoclassification and Metadata – Enhancing Efficiency and Compliance.

About this event


Date: 26th March

Time: 17:00 CET

AI in eTMF – Auto-Classification and Metadata: Efficiency and Compliance

What to expect?

  • First-hand experience: Demo of automated filing of documents and metadata assignment in the eTMF system by Evgenia Michalcuk-Vrablik, Flex Databases.
  • AI validation and control: What should be delivered by the tech provider, presented by Malik Bilgin, Flex Databases.
  • Assuring GxP compliance of embedded AI applications: The customer perspective, presented by Dr. Nico Erdmann, Deloitte.

Have questions about AI in eTMF? This is the perfect opportunity to get them answered.

You can now take a picture of a document with your phone, email it to eTMF, or drag and drop a document into eTMF, and it will be automatically filed in the correct place with automatically added metadata. Embracing innovation, we leverage AI for our daily chores.

But! Aren't we all also curious (and perhaps worried) about what should be done from the Sponsor or CRO perspective to ensure everything is compliant? Join our webinar to see AI in action and hear from our guest speaker from Deloitte on assuring compliance of embedded AI applications.

Guest Speaker:

Dr. Nico Erdmann is a Senior Manager at Deloitte Germany, where he is part of a Life Sciences team dedicated to transformation in the GxP environment. He leads the IT quality practice for CSV and AI Compliance in Life Sciences, overseeing all computerized validation projects, developing validation approaches for new technologies and IT quality frameworks. With respect to AI, he develops frameworks for ensuring GxP compliance of ML applications in regulated environments and supports companies in preparing frameworks for the EU AI Act. Nico is a standing member of the ISPE GAMP® D-A-Ch group on AI Validation and has published multiple articles on this subject.

Hosted by

  • Guest speaker
    DE G
    Dr. Nico Erdmann Manager Regulatory Risk @ Deloitte Deutschland

  • Team member
    MB T
    Malik Bilgin

  • Team member
    FD T
    Flex Databases

  • Team member
    EM T
    Evgenia Michalčuk

Flex Databases

Manage all your clinical trial processes in real time with a single secure and compliant to regulations eClinical platform