One of our most praised presentations, this Webinar by renowned eCTD expert Antoinette Azevedo will provide an overview of best practices to enable a sponsor to prepare a compliant eCTD for regulatory authority review. So you can avoid a costly Refuse-to-File (RTF) by FDA.
6 Things You will Learn:
Top issues regulatory authorities have with eCTD and how to avoid them.
Preparing submission-ready source documents and datasets for submission in eCTD.
Whether to purchase an eCTD publishing system or to outsource.
The role of an electronic document management system (EDMS) in an eCTD publishing solution?
How to prepare for the technical challenges of eCTD.
How to interact with regulatory authorities to assure your eCTD submission is accepted for review.
For More Information Please Click Here How to Avoid the Dreaded Refuse-to-File, Plus 2012 eCTD Mandate from Congress
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