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Regulators and Industry Discuss Digital Transformation and Pharma 4.0™

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Iacovelli stressed and Buendia concurred that digitization should be preceded by well-developed business cases that clearly define the purpose, target, and business value, then the “people aspects” of the change, and finally, the supporting technology. It must be people who make decisions about batch release.

FDA 97
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Regulators Discuss Harmonization & Innovation, Regulatory Agility & Speed, & Workforce Skills

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Rosa also indicated that US FDA has the Emerging Technology Team (ETT,) and he also stressed the need for early engagement since late engagement can lead to problems and delays. As Rosa commented “be prepared to teach us”. Rosa stressed that FDA was seeing a great deal of silo behavior in large companies.