Trk 07: Tech-Data- Records-Subs [
clear filter]
10:45am EDT
#132: Electronic Implementation of New PRO Measures to Assess Treatment Benefit in Irritable Bowel Syndrome Trials: Lessons Learned
Chair 
Executive Director, PRO Consortium, Critical Path Institute
Stephen Joel Coons is Executive Director of the Patient-Reported Outcome (PRO) Consortium at Critical Path Institute (C-Path). C-Path, an independent nonprofit organization, established the PRO Consortium in cooperation with the U.S. Food and Drug Administration and the pharmaceutical...
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Senior Vice President, Strategic Development and Corporate Marketing, Bracket
Mr. Butler is the Senior Vice President of Strategic Development at Bracket. Bracket offers a unique suite of solutions, with a unique perspective on clinical research development. Mr. Butler is responsible for Strategic Development for Bracket’s service offerings in Randomization...
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Vice President, Product Strategy and Innovation, YPrime Inc
Cindy Howry is nationally recognized thought-leader in the area of eCOA which empowers the patient and engages them to maintain and improve their health, simultaneously enabling clinical teams to have real-time access to better quality clinical data. Ms. Howry has more than 30 years...
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Clinical Outcome Assessments (COA) Staff, OND, CDER, FDA
Sarrit Kovacs, PhD is a reviewer with the Clinical Outcome Assessments (COA) Staff in the Office of New Drugs (OND) in the Center for Drug Evaluation and Research (CDER) at FDA. Sarrit has nearly 20 years of social science research experience and is a consultant to CDER and other...
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President and Founder, Albemarle Scientific Consulting LLC
David is VP, Data Science and Head, Study Endpoints at Ironwood Pharmaceuticals located in Cambridge, Massachusetts. The Data Science group is responsible for development of analytical strategies bridging early phase research through development into the biopharmaceutical product...
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Monday June 27, 2016 10:45am - 12:00pm EDT
204C
Pennsylvania Convention Center 1101 Arch Street, Philadelphia, PA 19107 USA
Trk 07: Tech-Data- Records-Subs,
Forum
- Credit Type ACPE, CME, IACET, RN
- Audience Intermediate
- Featured Topics Disease Specific, Disruptive Technologies
- Interest Area eClinical, Study Endpoints
- format json
- Interest Area eClinical,Study Endpoints
- Featured Topics Disease Specific,Disruptive Technologies
- Credit Type ACPE, CME, IACET, RN
- Tags Forum
10:30am EDT
#217: Electronic Submissions Gateway: Next Generation
Chair 
Senior Informatics Advisor, Office of the Director, CBER, FDA, United States
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...
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IT Program Manager, Electronic Submissions Gateway, OIMT, OC, FDA
La Misha Fields is the Program Manager of the FDA’s Electronic Submissions Gateway (ESG) under the Office of Information Management and Technology located in Rockville, MD. She is an informatics and technology professional with over 6 years of FDA experience, including 5+ years...
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Senior Project Manager, BSS, CBER, FDA
Mark has over 30 years experience in Information Management including; software developer/project manager in CBER; Director of Applications Development & Services in CDER; and PDUFA IT Program Director. Mark currently work’s for CBER’s Bioinformatics Support Staff. His responsibilities...
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Director, Div. of Data Management Services & Solutions, OBI, OSP, CDER, FDA
Ginny Hussong has over 20 years of experience in the pharmaceutical industry, of which the past 10 have been in CDER. As Acting Director of the Division of Data Management Services and Solutions, she supports the receipt, processing and archive of electronic regulatory submissions...
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Chief, Data Standards Program, CBER, FDA
Ginny Hussong is Chief of CBER’s Data Standards Program, and has been with FDA for 14 years. She was previously Director of Data Management Services and Solutions within CDER. As Chair of CBER’s Data Standards Committee, Ginny’s recent projects include creating a new joint data...
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Tuesday June 28, 2016 10:30am - 11:45am EDT
201C
Pennsylvania Convention Center 1101 Arch Street, Philadelphia, PA 19107 USA
10:30am EDT
#313: The Future of Clinical Research Data: 2020 and Beyond
Chair 
Chief Technology Officer, HL7
Mr. Kubick is CTO for Health Level Seven International, intent on improving clinical research through technology and data standards. He was formerly CTO and a Board member for CDISC, and has 2+ decades in a variety of leadership roles in clinical R&D with BBN, Parexel International...
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Managing Director, Accenture
Dave Evans is a senior technology and clinical research executive with over 35 years of experience in the clinical research, regulatory and healthcare industries. He is recognized industry-wide as a leading technology visionary for developing and implementing complex process and...
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Director, Research Professor, Tufts Center For the Study of Drug Development
Kenneth A. Getz, MBA, is the Deputy Director and Professor at the Tufts Center for the Study of Drug Development, Tufts University School of Medicine, where he directs research programs on drug development management strategy and practice. He is also the Founding Chair of the Center...
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President and Chief Medical Officer, Semantica LLC
His expertise includes clinical data standards, regulated study data submissions, and regulatory submission and review policy. A former Associate Director for Informatics in OCS, he focused on developing, adopting, and implementing clinical data standards to support premarketing assessment...
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Wednesday June 29, 2016 10:30am - 11:45am EDT
204B
Pennsylvania Convention Center 1101 Arch Street, Philadelphia, PA 19107 USA
