2. What is the purpose of a non-technical summary of the ED?
Apart from the fact that this is a regulatory obligation, it was born of an identified need. So there are at least two reasons for this ED RNT:
make the information contained in the study rapidly accessible, especially to people unfamiliar with this type of document;
allow you to step back and check the consistency of the information given in the DE, but also in the EI, and to validate its content.
The ED is a complex document, often incorporating numerous definitions, analyses of various "catastrophic" scenarios and calculation notes. In the vast amount...
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What is the purpose of a non-technical summary of the ED?