Diabetes Technology Society Presents:Agenda
Monday, September 9, 2013
SESSION 1: ASSURING THE AVAILABILITY OF SAFE AND EFFECTIVE BLOOD GLUCOSE TEST STRIPS
8:30 Introduction to the Meeting
David Klonoff
University of California at San Francisco, San Francisco, CA
8:35 Moderator Call to Order
Robert Vigersky
Walter Reed National Military Medical Center, Bethesda, MD
8:40 Current Performance of Cleared Monitors
Mitchell Scott
Washington University, St Louis, MO
8:55 Modeling Data of Poorly Performing Blood Glucose Monitors
Boris Kovatchev
University of Virginia, Charlottesville, VA
9:10 Factors Affecting Postmarket Performance of Cleared BG Monitors
Jan Krouwer
Krouwer Consulting, Sherborn, MA
9:25 Q & A / Group Discussion
9:40 Coffee Break
SESSION 2: SURVEILLANCE PROGRAMS
10:05 Moderator Call to Order
Courtney Lias
Food and Drug Administration, Silver Spring, MD
10:10 History of the National Glycohemoglobin Standardization Program (NGSP)
Randie Little
University of Missouri, Columbia, MO
10:25 How the National Glycohemoglobin Standardization Program (NGSP) and the College of American
Pathologists (CAP) Proficiency Testing Programs Improve Quality
David Sacks
National Institutes of Health, Bethesda, MD
10:40 The Cholesterol Reference Method National Laboratory
Eric Sampson
Sampson Consulting, LLC, Bowie, MD (Formerly at CDC and FDA)
10:55 The Norwegian Centre for Quality Assurance of Laboratory Services in Primary Care (NOKLUS)
Grete Monsen
Scandinavian Evaluation of Laboratory Equipment for Primary Health Care Bergen, Norway
11:10 Steroid Hormone Surveillance Program
Hubert Vesper
Centers for Disease Control and Prevention, Atlanta, GA
11:25 The Maryland Vehicle Inspection Program
Ira Cox
Vehicle Emissions Inspection Program, Glen Burnie, MD
11:35 Q & A / Group Discussion
11:55 Lunch Break
SESSION 3: A SOLUTION
12:55 Moderator Call to Order
Robert Vigersky
Walter Reed National Military Medical Center, Bethesda, MD
13:00 The Diabetes Technology Society Blood Glucose Monitor Surveillance Program
David Klonoff
University of California at San Francisco, San Francisco, CA
13:15 FDA Perspective on the Diabetes Technology Society Blood Glucose Monitor Surveillance Program
Courtney Lias
Food and Drug Administration, Silver Spring, MD
13:30 Q & A / Group Discussion
SESSION 4: INDUSTRY PERSPECTIVES
14:00 Moderators Call to Order
David Klonoff
University of California at San Francisco, San Francisco, CA
Katherine Serrano
Food and Drug Administration, Silver Spring, MD
14:05 Panel Discussion
Steve Scott, Abbott Diabetes Care
David Simmons, Bayer Diabetes Care
Alan Cariski, LifeScan, Inc.
Jeff DuBois, Nova Biomedical Corp.
Eric Kolodziej, Roche Diagnostics
Frank Flacke, Sanofi
Courtney Lias, Food and Drug Administration
15:05 Coffee Break
SESSION 5: CLINICAL AND LABORATORY PERSPECTIVES
15:30 Moderators Call to Order
David Klonoff
University of California at San Francisco, San Francisco, CA
Katherine Serrano
Food and Drug Administration, Silver Spring, MD
15:35 Panel Discussion
David Sacks, American Association for Clinical Chemistry (AACC)
Jane Seley, American Association of Diabetes Educators (AADE)
Robert Ratner, American Diabetes Association (ADA)
Hubert Vesper, Centers for Disease Control and Prevention (CDC)
Elizabeth Koller, Centers for Medicare & Medicaid Services (CMS)
Bennet Dunlap, Diabetes Online Community, StripSafely (DOC)
Andrew Boulton, European Association for the Study of Diabetes (EASD)
Courtney Lias, Food and Drug Administration (FDA)
Aaron Kowalski, Juvenile Diabetes Research Foundation (JDRF)
Guillermo Arreaza-Rubin, National Institutes of Health (NIH)
Gary Puckrein, National Minority Quality Forum (NMQF)
Robert Vigersky, The Endocrine Society (TES)
SESSION 6: CONCLUSIONS
16:35 Where Do We Go From Here?
Courtney Lias
Food and Drug Administration, Silver Spring, MD
16:45 Concluding Remarks
David Klonoff
University of California at San Francisco, San Francisco, CA
17:00 Adjourn