www.fdanews.com/articles/176908-ema-review-to-identify-faults-in-phase-1-trial-guidelines
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EMA Review to Identify Faults in Phase 1 Trial Guidelines
June 3, 2016
EMA is reviewing its guidelines for Phase 1 trials in the wake of a fatally flawed French study, with an eye toward issuing proposed revisions in July.
The agency has convened two teams of experts for the review, one focusing on pre-clinical issues and the data needed to safely initiate Phase 1 trials, while the other group will consider ways to improve trial design to better ensure participant safety, the EMA announced.
This dual-path review is expected to produce a concept paper of proposed changes in July, which itself is intended to spur an EU-wide discussion for revising the guidelines.