Trk 07: Tech/Data/ Records/Subs [
clear filter]
10:45am EDT
#131: IDMP Update
Chair VP
Senior Advisor for Regulatory Science, IDMP Topic Lead, CBER, FDA
Capt. Vada A. Perkins, MSc, BSN, RN, is the Deputy Associate Director for Review Management (acting) with the FDA's Center for Biologics Evaluation and Research, Office of the Director. He received his MSc. in Bioscience Regulatory Affairs from The Johns Hopkins University and his...
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Speakers
Principal Consultant, NNIT A/S
With a professional and academic bacground within the pharmaceutical industry Niels Grønning possesses extensive knowledge within the area of IT & Life Sciences. His area of expertise is predominantly found within regulatory affairs, IT (strategy, architecture & compliance) and more...
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Director, Life Sciences, Accenture Accelerated R&D Services
A Neuroscientist by training, Tom has worked in most therapeutic areas during time at Ipsen, Parexel and as a freelance consultant. Now at Accenture, he continues to represent clients to EMA and to facilitate drug development strategies; but also works with emergent technologies/concepts...
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Monday June 27, 2016 10:45am - 12:00pm EDT
204B
Pennsylvania Convention Center 1101 Arch Street, Philadelphia, PA 19107 USA
10:30am EDT
#216: Implementing a Successful Metadata Repository: The Journey of a Thousand Milestones Begins with a Single Step
Chair
Senior Director, Industry Strategy, d-Wise
Dave Handelsman is a life sciences expert with 25 years of industry, software and management experience. As Senior Director of Strategy and Product Development at d-Wise, Dave is responsible for d-Wise’s growth and evolution, and for further establishing d-Wise as the go-to partner...
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Speakers
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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Vice President, PAREXEL Informatics
Isabelle de Zegher is Vice President, Integrated Solutions at PAREXEL Informatics where she is responsible for engineering strategy around Big Data, BI and Advanced Analytics. She has 25 years’ experience in Life Sciences, including extensive work on cross-industry forum on integration...
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Tuesday June 28, 2016 10:30am - 11:45am EDT
204C
Pennsylvania Convention Center 1101 Arch Street, Philadelphia, PA 19107 USA
Trk 07: Tech/Data/ Records/Subs,
Session
- Credit Type CME, IACET, RN
- Audience Intermediate
- Interest Area Clinical Data Management, Regulatory Affairs, Information Technology, Statistics
- format json
- Interest Area Clinical Data Management,Regulatory Affairs,Information Technology,Statistics
- Credit Type CME, IACET, RN
- Tags Session
4:00pm EDT
#264: FDA Update on Data Standards
Chair
Director, Office of Strategic Programs, CDER, FDA, United States
Ms. Slack has 30+ years extensive leadership and management experience in both the public and private sectors, developing informatics strategy and implementing business solutions. She currently serves as Director of FDA CDER Office of Strategic Programs, which plays a lead role in...
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Speakers
Lead Medical Officer, OCS, OTS, CDER, FDA
Eileen Navarro is Associate Director for Clinical Affairs in the Office of Computational Science, OTS, CDER, where she leads a team of analysts in providing regulatory review and training support to medical officers, statisticians, and safety evaluators. She is a Fellow of the American...
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Project Management Officer, Office of Strategic Programs, CDER, FDA
Colleen Ratliffe is a project management officer on the Data Standards team within the Office of Strategic Programs, CDER. The data standards team’s core functions include coordinating and leading projects that support and promote the development of data standards and policy and...
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Director, Division of Biometrics III, Office of Biostatistics, OTS, CDER, FDA
Dr. Wilson has worked as a Statistical Reviewer and Supervisory Mathematical Statistician in FDA/CDER for 28 years and is currently the Director of the Division of Biometrics III and a Captain in the USPHS. He received his doctorate in Biostatistics from UNC/Chapel Hill in 1984.
Tuesday June 28, 2016 4:00pm - 5:15pm EDT
204B
Pennsylvania Convention Center 1101 Arch Street, Philadelphia, PA 19107 USA
Trk 07: Tech/Data/ Records/Subs,
Session
- Credit Type ACPE, CME, IACET, RN
- Audience Intermediate
- Featured Topics Agency Participation
- Interest Area Submissions, Clinical Data Management, Information Technology, Regulatory Affairs, eClinical
- format json
- Interest Area Submissions,Clinical Data Management,Information Technology,Regulatory Affairs,eClinical
- Featured Topics Agency Participation
- Credit Type ACPE, CME, IACET, RN
- Tags Session
4:00pm EDT
#265: Enabling Innovative New Endpoint Measurement Using Mobile Technology
Chair
Senior Director of Product Innovation, and Vice Director of ePRO Consortium, ICON, plc.
Bill serves as a Senior Director within Product Innovation at ICON, focusing on harnessing new technologies for clinical trials. He has worked in the Pharma industry for over 25 years and is the author of 60+ publications and an industry textbook on electronic Patient Reported Outcomes...
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Speakers
Global Head, Early Development Workflows, F. Hoffmann-La Roche Ltd.
Christian is leading the Early Development Workflow team in Roche’s Research and Early Development Informatics (pREDi) organization. He is driving technology innovation into clinical trials - focusing currently on the adoption of mobile sensors for digital biomarker development...
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Tuesday June 28, 2016 4:00pm - 5:15pm EDT
203AB
Pennsylvania Convention Center 1101 Arch Street, Philadelphia, PA 19107 USA
Trk 07: Tech/Data/ Records/Subs,
Session
- Credit Type ACPE, CME, IACET, RN
- Audience Intermediate
- Featured Topics Disruptive Technologies, Increasing Research and Development Innovation, Mobile-Wearable Technology
- Interest Area Study Endpoints, eClinical, Clinical Research, Clinical Data Management
- format json
- Interest Area Study Endpoints,eClinical,Clinical Research,Clinical Data Management
- Featured Topics Disruptive Technologies,Increasing Research and Development Innovation,Mobile/Wearable Technology
- Credit Type ACPE, CME, IACET, RN
- Tags Session
2:00pm EDT
#340: eSource: Using Source Data Capture from Electronic Health Records to Improve Clinical Research
Chair
Managing Partner, Fathom Digital Healthcare Consulting
20+ years’ experience in clinical R&D. Previously Head of Digital Healthcare for CDISC. Prior to that 15 yrs at Pfizer, leading implementations of global systems. Pioneered ASTER - the first time AEs were retrieved directly from an EHR and sent to FDA. Current work FDA project to...
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Speakers
Product Manager, Maestro Care (Epic) for Research and eSource, Duke University
Amy Nordo RN/BSN, CPHQ, LNC, MMCi is a Product Manager for Duke University’s Office of Research Informatics. Amy draws upon her previous experience as critical care nurse, clinical research coordinator, healthcare quality professional and Epic credentialed trainer. In her current...
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Associate Director, Medical Informatics, Office of Translational Science, CDER, FDA, United States
Mitra Rocca joined FDA in 2009 as the Senior Medical Informatician responsible for developing the health information architecture of the Sentinel System. She leads the FDA CDER Health Information Technology board and serves as the medical informatics expert at CDER. Prior to joining...
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Director, Global Biometry Standards, UCB Biosciences, Inc.
Trisha is currently the Director of Global Integrated Standards at UCB. She’s been in the pharma industry for over 20 years. Her work at UCB includes standards governance; overseeing a Metadata Repository (MDR) build; and initiating an Electronic Healthcare Record (EHR) data retrieval...
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Wednesday June 29, 2016 2:00pm - 3:15pm EDT
204C
Pennsylvania Convention Center 1101 Arch Street, Philadelphia, PA 19107 USA
Trk 07: Tech/Data/ Records/Subs,
Session
- Credit Type CME, IACET, RN
- Audience Basic
- Featured Topics Agency Participation, Electronic Health Records (EHR)
- Interest Area Clinical Research, eClinical, Clinical Data Management, Regulatory Affairs
- format json
- Interest Area Clinical Research,eClinical,Clinical Data Management,Regulatory Affairs
- Featured Topics Agency Participation,Electronic Health Records (EHR)
- Credit Type CME, IACET, RN
- Tags Session