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Tuesday, June 20 • 4:00pm - 5:15pm
#270: Data Quality

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

This session will discuss data quality in the light of risk-based methodologies: data fit for purpose, appropriate risk treatment, and quality by design.

Learning Objectives

Discuss if and how the approach to data quality has evolved with the adoption of risk-based methodologies.

Chair

Teresa Ancukiewicz, MA

Speaker

A Quality by Design Approach to Data Quality
Erik Doffagne, MS

Going Beyond Data Collection to Ensure Data Quality
Kenneth Stoltzfus

Model Data Management Plan
Scott Brand, PhD



Moderators
avatar for Teresa Ancukiewicz

Teresa Ancukiewicz

Senior Manager, Clinical Data Management, Boston Scientific Corporation
Senior Manager in Clinical Operations at Boston Scientific, CCDM. Responsible for providing leadership on outsourcing initiatives and Risk Based Monitoring. Over 20 years of experience in data management, process development and improvement, and vendor management. Active in the D... Read More →

Speakers
avatar for Teresa Ancukiewicz

Teresa Ancukiewicz

Senior Manager, Clinical Data Management, Boston Scientific Corporation
Senior Manager in Clinical Operations at Boston Scientific, CCDM. Responsible for providing leadership on outsourcing initiatives and Risk Based Monitoring. Over 20 years of experience in data management, process development and improvement, and vendor management. Active in the D... Read More →
avatar for Scott Brand

Scott Brand

Principal Scientist Data and BioInformatics, FEFA, LLC
Scott Brand is Principal Scientist Global Data and BioInformatics for FEFA LLC. He has 40 years experience in science and the pharmaceutical industry. Scott has a PhD in biology and carried out research in quantitative biology. He then had two postdocs at Harvard and Yale Medical... Read More →
avatar for Erik Doffagne

Erik Doffagne

Product Manager, CluePoints
Erik holds a bachelor degree in Computer Science and a master degree in Biostatistics. He has more than 10 years of experience in the life science industry. Erik has spent the last 5 years at developing methodology and technology for central statistical monitoring. Erik has co-au... Read More →
KS

Kenneth Stoltzfus

Clinical Data Strategies, Accelerated R&D Life Sciences, Accenture Accelerated R&D Services
Ken Stoltzfus has 26 years of broad experience in the pharmaceutical industry that ranges from data management to SAS programming to standards governance. Ken has led assessments, designs and implementations of CDISC data standards, along with the recommended strategies to achiev... Read More →


Tuesday June 20, 2017 4:00pm - 5:15pm
N426a McCormick Place 2301 South Martin Luther King Jr. Drive, Gate 4 Chicago, IL 60616