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Getting Ready for the Clinical Trial Regulation

By admin | Mar 17, 2021 | Comments Off on Getting Ready for the Clinical Trial Regulation

It’s been a difficult year for many biopharma companies and perhaps even more so for clinical research organisations, with Covid-19 forcing the postponement or even cancellation of many if not most clinical trials.  It is however important to keep a finger on the pulse of the other imminent regulatory changes that will impact work programmes …

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Medical Devices Back in the Spotlight

By admin | Feb 24, 2021 | Comments Off on Medical Devices Back in the Spotlight

The global disruption caused by the pandemic meant regulatory plans for 2020 needed to be delayed to give the life sciences industry and authorities breathing room. However, it is important to keep up to date with imminent regulatory changes that will impact the industry. In my last blog in this series (Getting Ready for the …

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Data protection to take centre stage in 2021

By admin | Jan 12, 2021 | Comments Off on Data protection to take centre stage in 2021

In early December, the EMA announced that it had been hit by a cyber-attack and that documents related to the Pfizer-BioNTech Covid-19 vaccines had been accessed. The agency issued a brief announcement after the attack to say a full investigation had been launched but provided no further details. The incident is a reminder to both …

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