Data Packages, Inspections & Delayed Submissions: EMA Addresses Frequent Questions About Raw Data Pilot

 
• By Neena Brizmohun

Is it permissible to use data packages prepared for other international regulators? This is among the many questions the European Medicines Agency has addressed about its new pilot on analyzing raw data from clinical trials.

Close up.employees discuss financial data. photo with copy space
The EMA is exploring if analyzing raw data is beneficial • Source: Alamy

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