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‘Let's Be Ambitious,’ EMA Official Says Of Tackling GDPR Issues In Clinical Trials

 
• By Vibha Sharma

The EU clinical trials transformation initiative that was introduced this year could help address the issues clinical trial sponsors face with data privacy legislation, according to a senior EMA official.

Hands typing on laptop computer at table with double exposure of online security virtual interface. Concept of data protection and blockchain.
EU GDPR has strict requirements for protecting the personal data of clinical trial participants • Source: Shutterstock

A senior European Medicines Agency official has highlighted how the nine-month-old Accelerating Clinical Trials in the EU (ACT EU) initiative could serve as a platform to address the challenges clinical trial sponsors face in complying with EU data privacy requirements in the General Data Protection Regulation (GDPR).

The “momentum of ACT EU” initiative should be harnessed to drive efforts on this front, according to Peter Arlett, head

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• By Bridget Silverman

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• By Craig Bleifer, Royce DuBiner, Max Bogost, Michael Brody, and Allyson Maur

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