Webcast | Virtual
Event Title
CDER SEND Common Issues and Policy Update
June 15, 2020
Event Title
CDER SEND Common Issues and Policy Update
- Date:
- June 15, 2020
- Time:
- 1:00 PM - 2:30 PM ET
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
LEARNING OBJECTIVES
- Identify the components of the KickStart service offered to FDA reviewers
- Describe common data fitness issues
- Evaluate possible solutions for the common data fitness issues sent to sponsors
- Describe useful CDER SEND policy updates
- Clarify CDER SEND requirements
SPEAKERS
Jesse Anderson, MPH
Program Manager, KickStart Service
Office of Computational Science | OTS | CDER | FDA
Jennifer Feldmann
Contractor
Patricia Brundage, PhD
Pharmacologist
Office of New Drugs | CDER | FDA
Stephanie Leuenroth-Quinn, PhD
Pharmacologist
Office of New Drugs | CDER | FDA