Regulatory Sourcebook eBook
Read the article:
How Artificial Intelligence Impacts the Global Regulatory Environment
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BioPharm International’s Regulatory Sourcebook eBook
Responsible data handling, the impact of mishandling data, and how organizations can implement ethical data best practices.
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In January 2020, Sumitomo Dainippon Pharma, a pharmaceutical company based in Osaka, Japan, and Exscientia, an artificial intelligence (AI) drug discovery company based in Oxford, United Kingdom, initiated a Phase I clinical study of DSP-1181. The drug, designed to treat obsessive-compulsive disorder, was created using AI technology. Through their combined efforts, the two organizations completed the exploratory research phase in under 12 months—a considerably shorter time frame than what is considered typical for this type of project (1). This is one example of AI-based products converging on the regulatory pathways toward mainstream health care.
Read this article in BioPharm International’s October 2021 Regulatory Sourcebook eBook.
Read the article:
How Artificial Intelligence Impacts the Global Regulatory Environment
Read the eBook:
BioPharm International’s Regulatory Sourcebook eBook
Rajesh Talpade is is senior vice president of Product at MasterControl.
BioPharm International
eBook: Regulatory Sourcebook eBook
October 2021
Pages: 22-25
When referring to this article, please cite it as R. Talpade, “How Artificial Intelligence Impacts the Global Regulatory Environment," BioPharm International Regulatory Sourcebook eBook (October 2021).
Guidance on Quality Culture Standards
June 3rd 2025Matt Cushing, VP of Quality and Science, Nelson Labs, and Susan J. Schniepp, distinguished fellow at Regulatory Compliance Associates, a Nelson Labs Company, discuss PDA/ANSI Standard 06-2025: Assessment of Quality Culture Guidance Documents, Models, and Tools, which was published in February 2025.