戻る Agenda
FDA Data Standards Update
Session Chair(s)
Ron Fitzmartin, PHD, MBA
Principal Consultant
Decision Analytics, United States
The Center for Drug Evaluation and Research and the Center for Biologics Evaluation and Research will implement a joint data standards strategy, with supporting action plan. The action plan is now a PDUFA VI commitment to industry. The strategy will be facilitated by the rules, regulations, and guidances that authorize FDA to require electronic standardized data in regulatory submissions. Supported by a data standards governance, the strategy’s key data standards goals and objectives fall into the following areas: pre-market review, post-market safety, and pharmaceutical quality.
The session will present the joint strategy, action plan, and updates such as SDTM / ADaM / SEND, therapeutic area standards, technical rejection of submissions, IDMP, and ICSRs. In addition, updates on the technical conformance guides and other technical specifications will be presented.
This session will provide updates on the data standards in development, supported and required and have an impact on sponsor's electronic submissions to the FDA.
Learning Objective : Explain the key data standards and impact on industry; Describe the key points of the FDA data standards strategy; Demonstrate an understanding of the data standards action plan and its projects.
Speaker(s)
CDER Perspective
Mary Ann Slack
FDA, United States
Director, Office of Strategic Programs, CDER
CBER Perspective
Ginny Hussong
FDA, United States
Branch Chief, Data Standards, CBER