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Tuesday, June 26 • 8:00am - 9:15am
#204: FDA Data Standards Update

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Component Type: Session
Level: Intermediate
CE: ACPE 1.25 Knowledge UAN: 0286-0000-18-557-L04-P; CME 1.25; IACET 1.25; RN 1.25

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 Objectives

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.

Chair

Ron D. Fitzmartin

Speaker

CDER Perspective
Mary Ann Slack

CBER Perspective
Virginia Hussong


Speakers
avatar for Ron Fitzmartin

Ron Fitzmartin

Senior Informatics Advisor, Office of Regulatory Operations, CBER, FDA, United States
Ron Fitzmartin is Senior Informatics Advisor, Office of Regulatory Operations, Center for Biologics Evaluation and Research, Food and Drug Administration. In this role Ron provides policy and strategy consultation and support on a wide range of topics focused on electronic regulatory... Read More →
avatar for Virginia Hussong

Virginia Hussong

Branch Chief, Data Standards, CBER, FDA, United States
Ginny serves as Chief of CBER's Data Standards Program, where she leads a multidisciplinary team that advances standards such as eCTD, SDTM, ADaM, SEND, ICSR, IDMP, SPL and related terminologies. In addition, the team leads reviewer training and support related to the review of study... Read More →
avatar for Mary Ann Slack

Mary Ann Slack

Director, Office of Strategic Programs, CDER, FDA, United States
Ms. Slack has 30+ years extensive leadership and management experience in both the public and private sectors, developing informatics strategy and implementing business solutions. She currently serves as Director of FDA CDER Office of Strategic Programs, which plays a lead role in... Read More →

Tuesday June 26, 2018 8:00am - 9:15am EDT
Room 209 Boston Convention and Exhibition Center 415 Summer Street, Boston, MA 02210 USA
  03: Data-Data Standards, Session