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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

Data Standards Staff, Office of the Director, CBER, FDA
Ron Fitzmartin is Senior Project Manager, Office of the Director, 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 submissions... Read More →
avatar for Virginia Hussong

Virginia Hussong

Chief, Data Standards Program, CBER, FDA
Ginny Hussong is Chief of CBER’s Data Standards Program, and has been with FDA for 14 years. She was previously Director of Data Management Services and Solutions within CDER. As Chair of CBER’s Data Standards Committee, Ginny’s recent projects include creating a new joint data... Read More →
avatar for Mary Ann Slack

Mary Ann Slack

Acting Director, Office of Strategic Programs, CDER, FDA
Ms. Slack has over 30 years’ technology and informatics experience implementing informatics solutions to business problems. Since joining FDA in 2003, she has been engaged in data standards development efforts in CDISC, HL7 and ISO in support of Agency needs. Ms. Slack is an FDA... Read More →

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