The Road to Explainable AI in GXP-Regulated Areas

About the Author

Model Developer

D-fine

Elias Altrabsheh started his career as a model developer working on health economics models in multiple therapeutic areas such as diabetes and infectious diseases. Since...

Martin Heitmann, FRM

Senior Manager

d-fine GmbH

Martin Heitmann is a Senior Manager at d-fine. In this role, he transfers process design, data science, and large-scale implementation expertise into ambitious digital transformation...

Patrick Steinmüller

Manager

D-fine

Patrick Steinmüller graduated from the University of Cambridge with an M.a.St. in Mathematics (Tripos Part III), and joined d-fine in 2016. He is a Manager...

Bruna Pastori Vinco

Validation & IT Quality Assurance Manager

Fresenius Kabi Deutschland GmbH

I am Validation Manager responsible for enforcing that all CSV functionalities be executed in compliance with the legal requirements and for ensuring quality in the...

Technical

Computer Software Assurance and the Critical Thinking Approach

1 March 2024

In 2022, the US Food and Drug Administration (FDA) issued their draft guidance “Computer Software Assurance for Production and Quality System Software”

Features

Digital Display Labeling in Clinical Supplies for Clinical Trials

1 March 2024

Digital display labels (DDLs) offer an alternative solution to eliminate manual relabeling in the clinical supply chain, optimizing label content updates through a simple, system-controlled approach while providing new, uncharted opportunities. With increased efficiency in making regulatory-compliant changes and enhanced flexibility in the clinical supply chain, DDL technology has the...

Features

Evolving China’s Regulatory System in Alignment with ICH

1 March 2024

With the Chinese government initiating drug regulatory reform in 2015 and China joining the International Council for Harmonisation (ICH) in 2017, a significant number of measures have been implemented by the government. The aim is to make fundamental changes to China’s drug regulatory administration system so it can facilitate pharmaceutical development and better meet patient needs in the...

About the Author

Facilities of the Future: Meeting the Demands of Breakthrough Therapeutics

Emerging Leader Hacker to GAMPer in 10 Weeks

New Initiative Seeks to Back up ICHs Harmonization Mission

Data Science-Assisted Biopharmaceutical Tech Transfer and Process Characterization

Entering a New Era of Innovation and Collaboration With the Focus on the Workforce of the Future

Q&A with ISPE Foundation Professional Development Grant Recipient Silas Tamufor

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