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Webcast | Virtual

Event Title
CDER SEND Common Issues and Policy Update
June 15, 2020

Date:
June 15, 2020
Time:
1:00 p.m. - 2:30 p.m. ET


View Slides

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

FDA RESOURCES

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