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Good Machine Learning Practices in GxP regulated areas
An overview on regulatory and industry initiatives
IT
Introduction
Regulatory Initiatives
US/FDA
EU
Other frameworks and recommendations
Industry work
Summary and conclusion
Regulatory Initiatives
US/FDA
EU
Other frameworks and recommendations
Industry work
Summary and conclusion
KeyWords, Trustworthy AI, Regulatory Initiatives , Enabling Innovation, European Commission, FDA, Collaborative Approach
Dr. Joerg Stueben1, Martin Heitmann2, Ingo Baumann3 · 1Boehringer Ingelheim International, Ingelheim, 2d-fine GmbH, Grünwald, 3Thescon GmbH, Coesfeld
 | Dr. Joerg Stueben works as “Head of Regulatory Information Management and Senior Expert” for Boehringer Ingelheim International. He oversees all typical activities of a RIM group with a focus on Data Management, IDMP/SPOR and Data Quality questions. He has a record of successfully leading cross-functional and compliance critical, global projects and consults his business in complex process questions. Joerg is a member of the GAMP D-A-CH Steering Committee and initiated the GAMP D-A-CH Working Group on GMP-compliant |
