SEND datasets: moving from a non-GLP to a GLP deliverable
SEND (Standard for Exchange of Nonclinical Data) is a nonclinical data standard produced to fulfill regulatory eCTD submission requirements. In December 2016 it became mandatory for nonclinical studies included in NDA, ANDA and certain BLA submissions and will become compulsory for INDs from December 2017.
Our Quality and Compliance Manager, Barbara Vaccarini, recently presented this scientific poster at the 5th Global QA conference 2017 in Edinburgh. She discusses key topics, including how, in order to claim GLP compliance -
• SEND should be included in GLP protocol
• SEND process/output should be audited by QA
• Study Director will be accountable for the dataset
Get your copy now and discover how to move from a non-GLP to a GLP deliverable.