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ABOUT THIS EVENT

In this webinar, CDER’s Office of Computational Science (OCS) will provide updates on the KickStart service, now known as the OCS Nonclinical Services and discuss updated data quality information focusing on submitted study data conformant to the Standard Exchange for Nonclinical Data (SEND) Implementation Guide version 3.1. Industry will be able to apply this knowledge to update their systems to avoid these errors in the future to increase usability of the SEND datasets for regulatory reviewers.

INTENDED AUDIENCE

• Regulatory affairs professionals who submit SEND data to CDER for review (INDs/NDAs/ANDAs/BLAs)
• CROs and/or consultants preparing and reviewing SEND datasets conformant to SENDIGv3.1 for Sponsors
• Staff of Standards Developing Organizations responsible for Implementation Guides for use by the Pharmaceutical Industry

TOPICS COVERED

• Updates to KickStart service delivery for nonclinical reviewers
• Common data findings in Clinical Data Interchange Standards Consortium - Standard for Exchange Nonclinical Data (CDISC-SEND) Datasets

FDA SPEAKERS

Jesse Anderson, MPH
Team Lead, Services Team
Division of Regulatory Review and Research (DRRR)
Office of Computational Science (OCS)
Office of Translational Sciences (OTS) | CDER | FDA

Benita Dharmaraj, MD., MHA
Project Manager, OCS Nonclinical Services
DRRR | OCS | OTS | CDER | FDA

Jennifer Feldmann, MS
OCS Contractor, SEND Subject Matter Expert
IBM | OCS | OTS | CDER | FDA

FDA RESOURCES

• CDSIC SEND
• FDA Data Standards Catalog
• FDA Guidance on Standardized Data

CONTINUING EDUCATION

Real-time attendance is required for the certificate of attendance which can be used in support of CEs for the following professional organizations. Certificates are only available during the two weeks post-event.

This course has been pre-approved by:

• RAPS as eligible for a maximum of 12 credits for a two-day event (appropriate to real-time attendance) towards a participant’s RAC recertification upon full completion.
• 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.
• SQA as eligible for 1 non-GCP or non-GLP unit for every 1 hour of instructional time towards a participant’s RQAP re-registration.
• ACRP for continuing education in clinical research. ACRP will provide 1 ACRP contact hour for every 45-60 minutes of qualified material.

TECHNICAL INFORMATION

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