CDER SEND Common Issues and Policy Update - 03/20/2020 - 03/20/2020 | FDA

CDER SEND Common Issues and Policy Update - 03/20/2020 - 03/20/2020 | FDA

CDER SEND Common Issues and Policy Update Friday, March 20, 2020 | 1:00 p.m. - 2:30 p.m.

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This CDER SBIA webinar is FREE. The Office of Computational Science’s (OCS) KickStart service provides data quality assessments to Pharm/Tox reviewers in the Office of New Drugs (OND). This webinar will discuss common issues seen in Sponsor-submitted data, how industry may address these issues, and provide CDER OND policy updates for industry. TOPICS Overview of the KickStart Service – data fitness and data exploration Common data quality issues and FDA methods for reaching out to sponsors CDER policy updates for sponsors INTENDED AUDIENCE Regulatory affairs professionals who submit SEND data to FDA for review CROs and/or consultants preparing and reviewing SEND datasets for Sponsors Staff of Standards Developing Organizations responsible for Implementation Guides for use by the Pharmaceutical Industries