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Bethesda North Marriott Hotel and Conference Center

Feb 10, 2020 8:30 AM - Feb 10, 2020 12:00 PM

5701 Marinelli Road, , North Bethesda, MD 20852 , USA

Short Course 2: Preparing and Submitting Standardized Study Data to FDA, Presented by FDA, CDER


Ethan  Chen, MBA, MS, PMP

Ethan Chen, MBA, MS, PMP

Director, Division of Data Management Services and Solutions, OBI, OSP, CDER, FDA, United States

Ethan Chen provides overall leadership to CDER in streamlining electronic and traditional submissions and delivering solutions to enable rapid adoption of emerging electronic data standards. Since joining the FDA in 2012, Mr. Chen has led several critical initiatives as the CDER Informatics Architect, including Data Management, Analytics and Business Intelligence, Electronic Submission and Portal Collaboration programs. Ethan has over 20-years’ experience in Data Management, Enterprise Architecture, Solution Development and System Integration.

Stephanie  Leuenroth-Quinn, PhD

Stephanie Leuenroth-Quinn, PhD

Pharmacologist, Office of New Drugs, CDER, FDA, United States

Stephanie Leuenroth-Quinn earned her Ph.D. in pathobiology before beginning her postdoctoral work in small molecule mechanism of action research. She joined the FDA in 2009 within the Division of Metabolism and Endocrinology Products (DMEP) in the Office of New Drugs (OND) as a nonclinical drug reviewer. Since 2017, Stephanie has been working on nonclinical policy and process initiatives within the Immediate Office of OND, including the Standard for Exchange of Nonclinical Data (SEND).

Helena  Sviglin, MPH

Helena Sviglin, MPH

Data Standards Advisor, FDA CDER Office of Strategic Programs, FDA, United States

Helena is the Chair of the Study Data Technical Conformance Guide (sdTCG) and the FDA Business Rules CCB

Heather  Crandall, MA

Heather Crandall, MA

Business Informatics Specialist, OBI, OSP, CDER, FDA, United States

Heather Crandall has been with the FDA since 2012, working in CDER’s Office of Business Informatics. She currently focuses on standards and processes around electronic submissions.

Hanming  Tu, MSc

Hanming Tu, MSc

Vice President, IT, Frontage Laboratories, Inc., United States

* MS, MCRP * VP, Clinical IT & Database Administration (DBA) at Frontage * Manager, DBA in Accenture Life Science Cloud * Director, Clinical IT in Octagon Research * Over 20 years of pharmaceutical and clinical IT experience * Oracle Certified Professional (OCP) and DBA Master from Oracle University. * Presented on emerging technologies, data standardization and visualization, and transformation and automation intelligence to the conferences such as DIA, CDISC Interchanges, PhUSE, etc.

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