MEPs Pass Clinical Trials Laws But Implementation Will Be Troublesome
This article was originally published in The Pink Sheet Daily
Europe’s parliamentarians have unsurprisingly and overwhelmingly voted in favor of the Clinical Trials Regulation – but implementation and transparency problems hover on the horizon.
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Agenda likely to include patient engagement, trial transparency and adaptive pathways for the well-respected leader who lost post due to procedural challenges.
Sweeping initiative to upgrade and standardize IT systems across Europe's drug regulatory network will also support enhanced pharmacovigilance and centralized applications process.
MHRA’s Beneficial EU Relationship And Profitable Synergies With NICE: An Interview With Michael Rawlins
In December, Michael Rawlins was appointed head of the U.K.’s Medicines and Healthcare products Regulatory Agency. He recognizes the MHRA’s mutually beneficial relationship with European counterparts and is looking to safeguard synergies with other national regulatory bodies and NICE.