The first thing you need to do is to set-up the secure communication with the FDA via the CESG.
This needs to be in place before you can send anything to the FDA, hopefully you are aware.
You can also use the help feature of the software and just build a mock submission that you will scrap at the end.
And during the process, one in your team is putting together a step by step manual, if the training provided by the software manufacturer is too confusing or not detailed enough, which it shouldn't.
If you are referring to the eCTD structure though, what goes where, then you need to use the eCTD FDA regulations, they should be detailed enough to tell you everthing.
Also, you can look at the ICH guidelines for the structure of modules 3, 4, and 5.
For an IND, you will probably need only Module 1 (which is country dependent - FDA regs apply in this case) and Module 3 for the CMC part of the application.
It's been a while since I worked on an FDA application, but the process is similar, not matter the market you apply in.
Hope this helps.
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Sorin Alb RAC
Project Manager, Regulatory Affairs
Scarborough ON
Canada
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Original Message:
Sent: 06-Nov-2019 10:22
From: alberto suarez
Subject: eCTD training
Hi Artur,
RAPS actually holds introductory and intermediate courses on eCTD training pretty regularly. I attended both courses when I had just started my position and they were very helpful for my company. https://www.raps.org/events/introduction-to-electronic-regulatory-submissions-in-the-ectd-format---november-2019. This one may be a bit too soon but there will likely be one coming up in the beginning on 2020.
Alberto
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alberto suarez
Regulatory Operations Specialist
Pittsburgh PA
United States
Original Message:
Sent: 05-Nov-2019 20:07
From: Artur Shchukin
Subject: eCTD training
Hello,
Can anyone please suggest any practical eCTD training, where my team can start using software and publish US NDA/IND etc.?
P.S.: please do not offer outsourcing.
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Artur Shchukin RAC, MS, ASQ-CQA
Manager, RA/QA
New York NY
United States
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