Module 1 2021

25/06/2021

• If you are going to work electronically, then make the changes to your processes and standards to gain the most benefit from the format: • Invest in the tools (document management, submission publishing tools and ancillary tools) • Implement the standards for the documents and require the authors in the functions to own them • Prepare to implement the CTD for all of your old products (and think “baseline”…) • Fully adopt the eCTD as the starting point for all of your submissions in all regions Developing a global electronic submission strategy (1)

The Organisation for Professionals in Regulatory Affairs

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• Your objective will be to author and publish the scientific and regulatory content only once ─ But do so in a way that maximises the way it can be reused • You will want to create content in an “electronic submission ready” state ─ eSub ready content can usually be printed out easily, but it’s not easy to take paper and include it in an electronic submission • You will want to develop the product (submission) strategy in a way that maximises the ability to reuse content ─ Write content so it can be reused in all regions ─ Look for ways to reuse one submission in another region (e.g. EU to Switzerland, EU to Australia, etc. • Begin with the end in mind! Developing a global electronic submission strategy (2)

The Organisation for Professionals in Regulatory Affairs

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