CDER SEND Common Issues and Policy Update - Webinar on June 15, 2020

CDER Small Business and Industry Assistance (SBIA) CDER SEND Common Issues and Policy Update Monday, June 15, 2020 | 1:00 p.m. - 2:30 p.m. Eastern

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This 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 CONTINUING EDUCATION Real-time attendance is required for attendance certificates which are only available during the two weeks after the event. This course: has been pre-approved by SOCRA who accepts documentation of candidate participation in continuing education programs for re-certification if the program is applicable to clinical research regulations, operations or management, or to the candidate's clinical research therapeutic area. has been pre-approved by RAPS as eligible for up to 12 credits towards a participant’s RAC recertification upon full completion. has been pre-approved by SQA as eligible for 0.25 non-GCP or non-GLP units for every 1 hour of instructional time towards a participant’s RQAP re-registration. has been approved by ACRP for medical education credits. Contact hours are provided at 1 unit for at least 45 minutes of qualified material..