Module 1 2021

25/06/2021

The need for tools

• There is an inherent complexity and technical nature to managing files for submissions • Simple tools for file management (file shares and Sharepoint) and document publishing (Adobe Acrobat) exist • Creating an eCTD also requires a means to generate the MD5 checksum (a comparison of two files to confirm they are exact copies) as a minimum • Creating an eCTD without a publishing tool is possible, but not recommended

The Organisation for Professionals in Regulatory Affairs

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The need for tools

• Regular interactions with HAs will probably lead you to the need for more sophisticated tools to support your processes • The EMA is committed to supporting Small and Medium Enterprises (SMEs) and have produced some simple tools to help certain processes • eCTD Validation tools are available for free • Is this a skill/capability to have in-house? • Vendor services are an increasingly popular way to support these activities • But don’t forget your oversight of the vendor’s work

The Organisation for Professionals in Regulatory Affairs

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