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
For more info: https://www.fda.gov/drugs/news-events-human-drugs/cder-send-common-issues-and-policy-update-03202020-03202020