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Pharma Industry Stresses Importance Of Getting EU Health Data Opt-Out Right

 
• By Eliza Slawther

Clinical trial sponsors could face an “extremely burdensome” experience if patients were allowed to opt out of their data being shared anonymously under the European Health Data Space, warns industry federation EFPIA.

Opt Out Mechanism
• Source: Shutterstock

EU citizens will have the option to oppose their data being used anonymously for secondary purposes once the European Health Data Space (EHDS) regulation enters into force, despite many stakeholders warning that this could undermine the aims of the new framework.

In a 25 September position paper, the European pharmaceutical R&D industry federation EFPIA set out key suggestions for member...

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UK’s Decentralized Manufacturing Rules Designed To Allow For ‘Future Developments’

 
• By Eliza Slawther

The UK drug regulator acknowledges that technology will “move on” and, as such, has designed its decentralized manufacturing regulation to be as “enduring” as possible. Experts from the MHRA explain what products are covered by the new framework and how it has been future-proofed.

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