SEND and the New Nonclinical Data Requirements for NDAs and INDs

November 13, 2018 10:00–11:00 Eastern Time (US & Canada)

This presentation will provide an overview of the SEND (Standard for Exchange of Nonclinical Data) and its impact on NDA and IND submissions. Topics covered will include: overview of the SEND 3.0 standard, submissions requirements for SEND datasets, SEND in the eCTD, working with nonclinical stakeholders to plan for SEND for submissions and a preview of the SEND 3.1 standard and the impact on submissions.

Presenter: Peggy Zorn, Senior Information Scientist, Instem

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