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Post-marketing surveillance studies are defined in Article 1(15) of Directive 2001/83/EC as studies carried out after a medicine has been authorised… Read more
The Unique Device Identifier system under the Regulation (EU) 2017/745 (MDR) and Regulation (EU) 2017/746 IVDR applies new requirements on… Read more
The seemingly never-ending Brexit negotiations have continued throughout the pandemic. Talks initially held virtually, have now progressed to face to… Read more
What changes could be made to the readability of package leaflets to make them more accessible for patients? Eileen Shortiss,… Read more
Previously, we looked at issues that arise within eCTD. Our Publishing Manager, Eileen Ryan, looks at eCTD validation issues in… Read more
The transition from paper-based submissions to the more costly eCTD system has caused many companies to reconsider how they undertake… Read more