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McCormick Place

Jun 18, 2017 8:30 AM - Jun 22, 2017 12:45 PM

2301 South Martin Luther King Jr. Drive, Gate 4, Chicago, IL 60616

DIA 2017 Annual Meeting

Evolving Data Standards and Regulations

Session Chair(s)

Ron  Fitzmartin, PhD, MBA

Ron Fitzmartin, PhD, MBA

Senior Advisor, Office of Regulatory Operations, CBER

FDA, United States

This session will describe the current state and evolution of data standards.

Learning Objective : Discuss the status of required study data standards, as well as other data standards initiatives; Summarize FDA's efforts to develop, test, and support therapeutic area data standards; Describe FDA's participation in and status of international data standards initiatives.

Speaker(s)

Vaishali  Popat, MD, MPH

Impact of the Binding Guidance for Standardized Study Data Internally at the FDA

Vaishali Popat, MD, MPH

FDA, United States

Branch Chief, Office of Clinical Evaluation,Office of Therapeutic Products, CBER

Dawn  Kaminski

CDASH v2.0: Whats New and What Does it Mean for Me?

Dawn Kaminski

eClinical Solutions, United States

VP Business Development Operations

Lauren  Becnel

CDISC Standards for Regulatory Submissions

Lauren Becnel

CDISC, United States

Vice President, Strategy and Innovation

Michael  Goedde

Metadata Driven Data Operations: What is it and How Can it Transform Traditional Clinical Data Management/Analysis/Reporting

Michael Goedde

PAREXEL, United States

Vice President, Clinical Data Management and Database Programming

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