Under the draft PDFUA V bill, electronic submissions will be mandated in Q2 2015. Given this recent news, GlobalSubmit offered this free webinar to provide a comprehensive overview of the eCTD, including everything from basics and terminology to rules and regional standards to submission output and solutions, and more. If you were able to join us, we hope that you now feel better prepared to make the switch from paper to eCTD.
We received several great questions during the webinar, but unfortunately did not have time to address all of them. Please find these questions and answers below.
Q: If a company is submitting its first eCTD, is it necessary that they first get some dummy file validated or checked by the USFDA and then submit the real dossier?
A: No. That said, if you are creating the submission by hand, then it would be a good idea to submit some dummy files first.
Q: What would you consider to be the best publishing and validation software?
A: We certainly feel that we have the best offering for publishing, validation, and review. Our VALIDATE and REVIEW products are the very tools used by the FDA, and so the need for quality is quite clear. PUBLISH has been built to be simple, intuitive, and easy to use, and is built on our solid foundation of VALIDATE and REVIEW
Q: Where can I get a copy of the ICH guidelines?
A: The current ICH eCTD specification, V3.2.2, can be found on the ICH website.
Q: How should SAE safety reports be submitted in eCTD and to which module are they submitted?
A: You should submit all serious adverse events through the FDA electronic submission gateway within the requisite time, preferably in ICSR format.
Q: What is the eCTD format for submitting Annual Report? Is there any guidance?
A: The FDA provides a submission type for submitting Annual Reports and an annual report is formatted in eCTD like all other submission types.
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