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POST-MARKETING Surveillance

What Are Post-Marketing Surveillance Studies?

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

Unique device identifier Acorn Regulatory explains

What Is A Unique Device Identifier?

The Unique Device Identifier system under the Regulation (EU) 2017/745 (MDR) and Regulation (EU) 2017/746 IVDR applies new requirements on… Read more

no deal Brexit Acorn Regulatory

Preparing for a No Deal Brexit – The 9th Acorn Regulatory Whitepaper

The seemingly never-ending Brexit negotiations have continued throughout the pandemic.  Talks initially held virtually, have now progressed to face to… Read more

GUIDE TO IMPROVING PACKAGE LEAFLET READABILITY

How To Improve The Readability of Package Leaflets

What changes could be made to the readability of package leaflets to make them more accessible for patients?  Eileen Shortiss,… Read more

eCTD validation issues the latest article from Acorn Regulatory

How To Fix Common eCTD Validation Issues

Previously, we looked at issues that arise within eCTD.  Our Publishing Manager, Eileen Ryan, looks at eCTD validation issues in… Read more

submission services ectd Acorn Regulatory

The 3 Options for eCTD Publishing & Submission Services

The transition from paper-based submissions to the more costly eCTD system has caused many companies to reconsider how they undertake… Read more

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