Tuesday, June 20 • 10:30am - 11:45am
#209: Evolving Data Standards and Regulations

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Component Type: Session
Level: Intermediate
CE: CME 1.25; IACET 1.25; RN 1.25

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

Learning Objectives

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.


Ron D. Fitzmartin, PhD, MBA


Impact of the Binding Guidance for Standardized Study Data Internally at the FDA
Vaishali Popat, MD, MPH

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

CDISC Standards for Regulatory Submissions
Lauren Becnel

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

avatar for Lauren Becnel

Lauren Becnel

Vice President, Strategy and Innovation, CDISC
Lauren Becnel leads strategy development, technologic and innovative programs at CDISC. Her projects include, for example, the SHARE metadata repository, which houses all CDISC standards; projects related to the CDISC, HL7 and ISO standard BRIDG translational research domain information... Read More →
avatar for Benedikt Egersdoerfer

Benedikt Egersdoerfer

Vice President, Global Data Operations, PAREXEL International
With over 20 years of experience in clinical research and the pharmaceutical industry, Dr. Egersdörfer has been instrumental in founding and leading departments responsible for the acquisition, integration, analysis, and reporting of data used in the Drug Development and Drug Safety... Read More →
avatar for Ron Fitzmartin

Ron Fitzmartin

Senior Informatics Advisor, Office of the Director, CBER, FDA
Ron Fitzmartin is Senior Informatics Advisor, 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 Michael Goedde

Michael Goedde

Vice President, Clinical Data Management and Database Programming, PAREXEL
Michael Goedde is a Certified Clinical Data Manager with more than 26 years of experience in the pharmaceutical and biotechnology industry. In his career he led CDM and programming groups at Aventis, Kos Pharma, HGS, Medimmune and PAREXEL. Michael serves on the Board of Trustees for... Read More →
avatar for Dawn Kaminski

Dawn Kaminski

Director, Clinical Data Strategies, Accenture Accelerated R&D Services
Dawn Kaminski has over 20 years of experience. With Accenture, Ms. Kaminski has provided consultation to organizations in the adoption of CDISC standards, served as a primary architect for an EDC system and consulted on clinical trial best practices. Dawn is a member of the CDASH... Read More →
avatar for Vaishali Popat

Vaishali Popat

Associate Director of Biomedical Informatics and Safety Analytics, OND, CDER, FDA
Dr. Vaishali Popat is an Associate Director for Biomedical Informatics in the Office of New Drugs, Immediate Office. Dr. Popat is the OND lead on biomedical informatics issues in areas such as staff training on the use of new review tools to make the evaluation of pre-marketing data... Read More →

Tuesday June 20, 2017 10:30am - 11:45am
N228 McCormick Place 2301 South Martin Luther King Jr. Drive, Gate 4 Chicago, IL 60616