eClinical Trial Management Summit
Agenda
| Day One – Monday, August 13, 2012 | ||
| 8:00 AM | Registration and Continental Breakfast For Workshop Participants | |
| 9:00 AM | Pre-Conference Workshop Robert Musterer, President, ER SQUARED, INC. | |
| 12:00 PM | Luncheon for Workshop Attendees/ Registration for Main Conference | |
| MAIN CONFERENCE BEGINS | ||
| Chair Welcome and Opening Remarks Munther Baara, Senior Director, Global Business Technology, | |
| 1:15 PM | Keynote: Regulations, Standards, and Expectations for a Fully Integrated eClinical System Douglas Fridsma, Acting Chief Scientist, Office of the National Coordinator for HIT, HEALTH AND HUMAN SERVICES | |
| 1:45 PM | Developing a Cross-Functional CTMS for Increased Clinical Data Quality Christa Allen-Jones, Operations Support Manager, | |
| 2:30 PM | Fast and Accurate Patient Recruitment Data Monitoring in order to Avoid Trial Start-Up Delays Munther Baara, Senior Director, Global Business Technology, | |
| 3:15 PM | Networking & Refreshment Break | |
| 3:45 PM | Case Study: Advanced Data Visualization Techniques for Clinical Trial Monitoring Victor Lobanov, PhD, Informatics, JANSSEN | |
| 4:30 PM | Driving Data by Creating an IVR Driven Collection Process
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| 5:15 PM | CASE STUDY: Assessing Investigator Site Systems for suitability for Clinical Trial Source Data Pat BeersBlock, Regulatory Consultant, ECLINICAL FORUM | |
| 5:45 PM | Day One Concludes | |
| Day Two – Tuesday, August 14, 2012 | ||
| 8:00 AM | Continental Breakfast | |
| Conference Chair Opening Remarks Munther Baara, Senior Director, Global Business Technology, | |
| 9:00 AM | Case Study: Utilizing Technology to Ensure a Continuous Cycle of Site Education Speaker TBD, UL EDUNEERING | |
| 9:45 AM | Utilizing eSource as a solution to Complex Data Management Issues Evonne Roberts, Senior Manager, | |
| 10:30 AM | Networking & Refreshment Break | |
| 11:00 AM | Supply Chain Concepts Applied to Clinical Trial Data Walt Townsend, Senior Manager, Electronic Data Quality Assurance, TAKEDA | |
| 11:45 AM | Overcoming Challenges in the Development & Configuration of the IVRS/IWRS System | |
| 12:30 PM | Luncheon | |
| 1:30 PM | Utilizing EHR for Patient Recruitment to Determine the Most Qualified Participants to Create the Best Patients for your Clinical Trial Stan W. Kachnowski, Professor, IIT DELHI, New Delhi India, Chair, HEALTHCARE INNOVATION TECHNOLOGY LAB, NEW YORK, NY USA, Fellow, ROYAL SOCIETY OF MEDICINE, ENGLAND
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| 2:15 PM | Utilizing Claims Data for efficient Post-Approval Drug Safety Surveillance Andres Gomez, PhD, MPH, GPV&E-Medical Safety Assessment, Executive Director – Head of Epidemiology, BRISTOL-MYERS SQUIBB | |
| 3:00 PM | Networking & Refreshment Break | |
| 3:15 PM | Understanding the Patient’s Perspective: Considerations for Electronic Capture of Patient Reported Outcome data Michelle Mocarski, Manager, Health Outcomes, Economics Research, FOREST LABORATORIES | |
| 4:00 PM | HL7 Perspective: Misconceptions of EHR Data and Making it Widely Available for Life Science Companies Charles Jaffe, MD, Ph.D., CEO, HL7 | |
| 4:45 PM | Chair Closing Remarks Munther Baara, Senior Director, Global Business Technology, PFIZER Stan W. Kachnowski, Senior Director, Global Business Technology, PFIZER | |
| 5:00 PM | Conference Concludes | |
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