Module 1 2021

25/06/2021

Electronic submissions: Region by region – The United States (4)

• Electronic submissions are made through the FDA Electronic Submission Gateway (ESG) making for a fully electronic process

The Organisation for Professionals in Regulatory Affairs

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Electronic submissions: Region by region – EU (1)

• The EU review processes and the autonomy of the individual EU Member States makes this a more complex environment to work in • However, the situation is a lot clearer now than it was just a few years ago • In addition, if you aim to optimise your investment in eCTD and use this format whenever you can then the number of issues are very much reduced

The Organisation for Professionals in Regulatory Affairs

40

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