 |
AGENDA SECRETARY'S ADVISORY COMMITTEE ON REGULATORY REFORM
Hyatt
Regency Minneapolis
Minneapolis,
MN
The Regency Room
June 10 - 11, 2002
| June
10, 2002 |
|
Committee
Chair Opens Meeting
Dr. Douglas L. Wood |
8:00
am |
Adverse
Event Reporting
Overview
Presentation
Steve
Galson, Deputy
Director, Center for
Drug
Evaluation and
Research, FDA, HHS
Panel
Discussion
Steven
B. Meisel, PharmD,
Assistant Director
Clinical Services,
Fairview Southdale
Hospital
Herbert
Slade, MD, Medical
Director, 3-M
Pharmaceutical Company
Debra
Shatin, PhD, Senior
Researcher, United Health
Group
Nancy
Sailer, Director
of Program Services,
Alzheimer's Association -
Minnesota Dakotas Chapter
Kristin
Johnson, Manager, Quality
and Regulatory
Compliance,
Boston Scientific
Corporation
|
8:05
am – 9:35 am |
|
BREAK |
9:35 am -
9:45
am |
|
Public
Comment |
9:45
am – 10:30 am |
Committee
Business
Review
of Agenda
Dr.
Douglas L. Wood
|
10:30
am - 10:45 am |
Discussion
Agenda Carryover from
Denver
- Data & Information
Subcommittee
|
10:45
am – 11:30 am |
-
Regulatory Flexibility
Subcommittee
|
11:30
am - 12:15 pm |
|
WORKING
LUNCH |
12:15
pm – 1:00 pm |
Discussion
Agenda Carryover from Denver (cont)
-
Communications and
Oversight
Subcommittee
|
12:30
pm – 1:15 pm |
-
Coordination
Subcommittee
|
1:15
pm – 2:00 pm |
Regulatory
Reform: Interim Report to the
Secretary
Secretary
Tommy
G. Thompson,
U.S. Department of Health
and Human Services
Dr. Douglas L. Wood,
Committee Chair
|
2:00
pm |
CMS
& FDA Approval Processes
of New Medical Technologies
Overview
Presentation
Dr.
David Feigal,, Director,
Center For Devices and
Radiological Health, FDA,
HHS
Dr. Sean Tunis, Acting
Deputy Director, Office
of Clinical Standards and
Quality, CMS, HHS
Panel
Discussion
Jim
Gardner, MD, Medical
& Science Officer,
Cook, Inc.
Marshall
Stanton, MD,
VP,
Arrhythmia Management,
Medtronic
John
Smith, MD, J.D., Director
of Regulatory Affairs,
Center for Integration of
Medicine and Innovative
Technology (CMIT)
Keith
Folkert, MD, MHA,
Medical
Director,
Blue Cross Blue Shield of
Minnesota
John
Hagman, Minnesota State
President, American
Association of Retired
Persons
|
2:30pm
– 4:00 pm |
| BREAK |
4:15
pm - 4:30 pm |
| Public
Comment |
4:30
pm – 5:15 pm |
Committee
Business
Discussion
Agenda Carryover
Dr.
Douglas L. Wood
|
|
| New
Consent Agenda items |
5:15
pm – 6:00 pm |
| Adjourn
for the Day |
6:00
pm |
|
June
11, 2002 |
|
State
–Federal Coordination of
Program Issues
Overview
Presentation
Leslie
Norwalk, Policy Director
&
Counselor
to the Administrator, CMS,
HHS
Panel
Discussion
Mary
Gavinski, Chief Medical
Officer,
Community Care
Organization, Inc.
Pam
Parker, Director,
Integrated Purchasing
Demonstrations,
Minnesota Department of
Human Services
Mark
R. Meiners, Ph.D.,
Director, University of
Maryland
Center on Aging
Richard
Bringewatt, President
& CEO,
National Chronic Care
Consortium
Wendy
Warring, Medicaid
Director, State of
Massachusetts
|
8:00
am – 9:30 am |
| Public
Comment |
9:30
am – 10:30 am
|
|
BREAK |
10:30
am – 10:45 am |
| Committee
Business |
10:45
am – 12:00 pm |
| LUNCH |
12:00
pm –1:00 pm |
| Committee
Business |
1:00
pm – 6:00 pm |
|
BREAK |
3:00
pm – 3:15 pm |
|
Committee
Meeting Adjourns |
6:00
pm |
|
|
|
