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


Instructors

  • Ethan  Chen, MBA

    Ethan Chen, MBA

    • 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 and Business Intelligence programs. While leading the CDER Division of Data Management Service and Solution, Ethan had successfully implemented the eCTD electronic submission mandate in 2017 for NDAs, BLAs and ANDAs, and again in 2018 for Commercial INDs and DMFs (excluding DMF Type III). 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

    • Operations Research Analyst, OBI, OSP, CDER
    • FDA, United States

    Heather Crandall has been with the FDA for over 6 years, 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.