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Executive Summary For most of life sciences history, validation has been a snapshot — freeze the configuration, prove it behaves as designed, trust the system until you change it. Nuno Valério has spent his career inside that paradigm, and he's now one of the clearest public voices on what has t...
About the Guest Crystal Allard is Senior Director of Government Strategy at Veeva Systems, where she works with regulators and industry to shape the future of the submissions ecosystem and increase speed to market. Crystal spent roughly 15 years at the FDA across innovation and technology roles...
Host: Matt Neal Guest: Scott Cleve, Vice President, Regulatory Operations, Information and Compliance, Daiichi Sankyo Executive Summary Few people have lived through more change cycles in regulatory operations than Scott Cleve. Across 20+ years at Accenture, AbbVie, Astellas, Boehringer Ingelhe...
Executive Summary Computer system validation in life sciences is at the most significant inflection point of the last 25 years. In this conversation, Matt Neal sits down with Bryan Ennis — co-founder of Sware and a 27-year veteran of regulated systems work at Genzyme and Veeva — to trace how val...
Why Biopharma Operating Models Collapse Under Scale What regulatory operations and R&D platforms reveal about how organizations actually function Most life sciences organizations don’t struggle because of regulation—they struggle because of how they interpret it. From the vantage point of ...
免责声明: 本页面嵌入的播客和封面图片来自 Matt Neal,归其所有者所有,与 Listen Notes, Inc. 无关联,也未获得 Listen Notes, Inc. 背书。