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Making EU Clinical Trials Regulation A Success ‘Takes All Of Us To Tango’

 
• By Eliza Slawther

Sponsors and regulatory agencies within the 27 EU member states must all be “committed” to working with the EU Clinical Trials Regulation in the most appropriate way to keep pace with other countries, including the UK where competition is heating up, says Miguel Forte, CEO of Kiji Therapeutics.

All stakeholders must be willing to 'Tango' if the EU Clinical Trials Regulation is to be a success (Shutterstock)
Key Takeaways
  • EU clinical trials are still lagging behind those of other comparable markets, despite the rollout of the Clinical Trials Regulation which was intended to speed up and harmonize clinical trial applications in the bloc.
  • If the CTR is to be a success, all stakeholders must make an effort to use its provisions appropriately, Miguel Forte, the CEO of Kiji Therapeutics says.
  • The UK is becoming faster and more flexible when it comes to clinical trials, which could help push the EU to improve, according to Forte.

While the EU’s clinical trials ecosystem is “moving in the right direction,” the region is “still lagging” behind other jurisdictions and could see competition from the UK, Miguel

Forte, who is also a board member of the Alliance for Regenerative Medicine advocacy group, said that the implementation of the EU Clinical Trials Regulation (CTR) has been “slow and rocky at some points,” but said that the overall

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