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ECG Labs & Cardiac Safety
ECG Labs & Cardiac Safety
| Special sessions just for ECG related content | |
| B1 Overcome Outsourcing & Operational Challenges for Smaller Companies | |
| 1:45 | Navigating ECG RFPs and Maximizing the Continuum of Service Kristian B. Hubbard, Research, Grants and Contracts, Clinical Pharmacology, Translational Medicine, Biostatistics and Anti Infective, EISAI MEDICAL RESEARCH |
| B3 Morning Half Day Workshop - Cardiac Safety | |
| 8:00 | Registration and Morning Coffee hosted by  |
| 9:00 | Workshop Begins |
| 10:30 | Networking Break |
| 12:30 | Networking Luncheon |
| Cardiac Safety: Premarketing Assessment for Noncardiac Drugs Workshop Leaders J. Rick Turner, PhD, Chairman, Department of Clinical Research, CAMPBELL UNIVERSITY SCHOOL OF PHARMACY Todd A. Durham, MS, Senior Director of Biostatistics and Data Management, INSPIRE PHARMACEUTICALS | |
B4 Afternoon Half Day Workshop - Echocardiography in Clinical Trials | |
| 1:00 | Registration hosted by |
| 1:45 | The Value & Increasing Importance of Echocardiography in Clinical Trials Polina Voloshko, Vice President, Medical Operations. CARDIOCORE Nelson Schiller, MD, FACC, Chair of Cardiology, University of California San Francisco, and Director of Echocardiography, SAN FRANCISCO VA HOSPITAL |
| 3:15 | Afternoon Networking Break |
| 3:45 | Centralizing Echocardiography in Clinical Trials William R. Shanahan, Jr. MD, JD, Vice President and Chief Medical Officer, ARENA PHARMACEUTICALS Julio E. Pérez, MD, Professor of Medicine, Director of Echocardiography, WASHING TON UNIVERSITYSCHOOL OF MEDICINE Tim Callahan, PhD, Chief Scientific Officer, BIOMEDICAL SYSTEMS |
| 5:15-6:45 | Networking Reception |
 Networking, Networking and More Networking!Please join us for the Partnering with Central Labs Welcome Reception Monday, January 26th, 5:15-6:45 Mingle with your colleagues and clients and have a drink on us! Join us as we welcome everyone and kick off our 7th Annual Conference. | |
| Tuesday January 27th, 2009 | |
| Track C: Improving and Standardizing ECG and Cardiac Safety Studies | |
| 1:30 | Chairperson’s Opening Remarks |
| 1:35 | Update on FDA Guidance for ECG Related Studies Jeffrey Litwin, MD, Chief Medical Officer & Executive Vice President, eRESEARCHTECHNOLOGY |
| 2:00 | ECG Data Integration and Standardization with CDM/ EDC Systems Jennifer Cotteleer, Chief Executive Officer, CARDIOCORE |
| PANEL DISCUSSION | |
| 2:30 | New Equipment and Software Technology Landscape Moderator: Tim Callahan, PhD, Chief Scientific Officer, BIOMEDICAL SYSTEMS Panelists: Dr. Tosja K. Zywietz, CARDINAL HEALTH RESEARCH SERVICES |
| 3:00 -3:45 | Networking Break in Exhibit Hall Hosted by: |
| MCC METRICS | |
| 4:15 | Using the MCC ECG Metrics Jeffrey Litwin, MD, Chief Medical Officer & Executive Vice President, eRESEARCH TECHNOLOGY Steve Asbury, Global ECG Coordinator, ELI LILLY & COMPANY |
| PANEL DISCUSSION | |
| 4:45 | Hot Topics and Trends in Cardiac Safety Studies Moderator: Tim Callahan, PhD, Chief Scientific Officer, BIOMEDICAL SYSTEMS Panelists: Matthew Spear, MD, Chief Medical Officer, Vice President, NEREUS PHARMACEUTICALS Invited |
| 5:15 | Tuesday Concludes |
| 5:15-6:45 | Reception in Exhibit Hall Hosted by  |
| Wednesday January 28th, 2009 | |
| 1:30 | Chairperson’s Opening Remarks |
| EXTENDED SESSION | |
| 1:35 | Working Together to Develop Biomarkers for Safety Monitoring and Surrogate Endpoints William Wheeler, MD, Chief Scientific Officer, MDS PHARMA SERVICES |
| 3:00 | Methods to Mitigate the Potentially Distorting Effect of Heart Rate in QT Analyses Lawrence Z. Satin, MD, FACC, Chief Medical Officer, CARDIOCORE TBA SHIRE PHARMACEUTICALS |
| 3:30 | Conference Concludes |
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