The proposed EHDS Regulation1 (Proposal), introduced in May 2022 by the European Commission (EC), aims to reform the “situation of fragmentation” that depicts th
Before getting lost in the vast options a decentralised clinical trial (DCT) setup provides, sponsors considering a DCT model need to keep in mind that it is not a one-size-fits-all approac
More than 5,000 collaborative studies were thwarted by GDPR rules in 2019 – but is there a way to protect sensitive data while still allowing international health research to thrive? <
Now that the GDPR deadline of May 25 has come and gone, many life sciences companies will have come to realise that GDPR compliance is not simply a legal problem or an IT project, but an enterprise
The EMA's human medicines committee has recommended against approval of Eisai and Biogen's Alzheimer's disease therapy Leqembi, after regulators in the US, China and Japan gave a green ligh