Note: This course takes place a day before the SCVS 2008 Annual Symposium on March 5 - 8, 2008.

This course is supported by an educational grant from:
This program is intended to provide individuals with an understanding of clinical trials and specific knowledge of the clinical research process in the context of vascular disease management.
Upon completion, participants should be able to:
This course is designed for vascular surgeons, trainees and research coordinators who are seeking to expand their knowledge related to the design, conduct, and evaluation of clinical trials.
The Society for Vascular Surgery (SVS) is accredited by the Accreditation Council for Continuing Medical Education (ACCME) to provide continuing medical education for physicians.
The SVS designates this educational activity for a maximum of 5.25 AMA PRA Category 1 Credits™. Physicians should only claim credit commensurate with the extent of their participation in the activity.
The course is supported by an educational grant from Abbott Vascular.
| Tuesday, March 4, 2008 | |
| 7:00-8:00 am | Registration and Continental Breakfast |
| 8:00-8:10 am | Introduction Peter L. Faries, MD Luis A. Sanchez, MD |
| 8:10-8:30 am | Why Become An Investigator Participating In Clinical Trials? – Advantages Jon S. Matsumura, MD |
| 8:30-11:30 am | Session I – Understanding Clinical Trials |
| 8:30-8:45 am |
Why Do We Perform Clinical Trials? – FDA Perspective |
| 8:45-9:00 am | Why Do We Perform Clinical Trials? – Industry Perspective Simona Zannetti, MD |
| 9:00-9:15 am | What Are The Attributes Of A Successful Site Stan Fink, PhD |
| 9:15-9:30 am | Ethics Of The Conduct Of Clinical Research Gregory L. Moneta, MD |
| 9:30-9:45 am | Break |
| 9:45-10:00 am |
Enhancing Compliance – Reviews and Inspections Ted Heise, PhD, RAC |
| 10:00-10:15 am |
How To Prepare Your Site For An FDA Audit Anne G Alexander, RN, CVN Richard J. Powell, MD |
| 10:15-10:30 am | Managing And Avoiding Conflict Of Interest Thomas J. Fogarty, MD |
| 10:30-11:00 am | Panel Questions |
| 11:00-11:30 am | Break |
| 11:30 am-1 pm | Session II – Initiating and Conducting Clinical Trials |
| 11:30-11:45 am |
How To Be Considered For Participation In A Clinical Trial |
| 11:45 am-12:00 pm |
Assembling Your Clinical Research Team Peter K. Henke, MD |
| 12:00-12:15 pm |
Anticipating And Managing Issues With Your IRB Gregory L. Moneta, MD |
| 12:15-12:30 pm |
Preparing A Contract (Insurance, Warranty, Indemnity, CRF) Ronald L. Dalman, MD |
| 12:30-12:45 pm | Economics Of Trial Participation (Budget Development, Research Personnel) Ronald L. Dalman, MD |
| 12:45-1:15 pm | Panel Questions |
| 1:15-2:00 pm | Lunch – Maximizing Patient Recruitment And Retention Richard J. Powell, MD, Moderator |
| 2:00-4:00 pm | Session III – Industry Exchange (This session is not included in the CME program) |
| Abbott Vascular | |
| Boston Scientific | |
| Cook Medical | |
| Cordis Endovascular | |
| Medtronic | |
| W.L. Gore & Associates, Inc. | |
| 4:00 pm | Adjourn |
*Program subject to change
Dorothy B. Abel
US FDA Center for Devices and Radiological Health, Rockville, MD
Peter L. Faries, MD, Course Director
Mount Sinai School of Medicine, New York, NY
Luis A. Sanchez, MD, Course Director
Washington University School of Medicine, St Louis, MO
Anne G. Alexander, RN, CVN
Dartmouth Hitchcock Clinic, Lebanon, NH
Pat Chuinard
Medtronic, Santa Rosa, CA
Ronald L. Dalman, MD
Stanford University Medical Center, Palo Alto, CA
Stan Fink, PhD
Abbott Vascular, Santa Clara, CA
Thomas J. Fogarty, MD
Portola Valley, CA
Ted Heise, PhD, RAC
Cook Medical, Bloomington, IN
Peter K. Henke, MD
University of Michigan Health System, Ann Arbor, MI
Jon S. Matsumura, MD
Northwestern Memorial Faculty Foundation, Chicago, IL
Gregory L. Moneta, MD
OR Health Sciences University, Portland, OR
Richard J. Powell, MD
Dartmouth Hitchcock Clinic, Lebanon, NH
Peyton Willert, MPH
Medtronic, Santa Rosa, CA
Simona Zannetti, MD
Medtronic Cardiovascular, Santa Rosa, CA
Disclosure statements have been requested from the faculty and will be made available at the conference. Faculty presenters are also expected to disclose to participants any discussions of off-label and/or investigational uses of pharmaceutical products and/or medical devices during their presentations.
Caesars Palace
3570 Las Vegas Boulevard
Las Vegas, NV 89109
Hotel Phone: 866-227-5938
Reservations: 866-227-5944
(Please ask for the SVS room block and refer to reservation code: SCCRL8)
Room Rate: $239 plus tax single/double
Reservation Deadline: Friday, February 1, 2008
| Meeting Registration Form |
Please call 800-258-7188 or email education@vascularsociety.org if you have questions.