Good Machine Learning Practices in GxP regulated areas
An overview on regulatory and industry initiatives
IT
KeyWordsTrustworthy AI | Regulatory Initiatives | Enabling Innovation | European Commission | FDA | Collaborative Approach
ABSTRACT
With ChatGPT, machine learning has become a mass phenomenon: Within a very short time, the 1 million user mark was exceeded, with just in a few months reaching a user base of 100 million - from private use to writing birthday invitations for children to business use such as chatbots for knowledge management. Even if the application of machine learning methodology is not new, this momentum has led to a substantially higher awareness in the pharmaceutical industry - ranging from enthusiastic to skeptical reactions. At the same time, regulators have launched a number of initiatives dedicated to embedding artificial intelligence and machine learning methods in existing regulations for computerized systems. In this article, we provide an overview of these initiatives and reference further industry work regarding good machine learning practices and governance.
 | 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 |
