Forum Speakers &
Attending Organizations
- American Hospital Association
- American Society of Health-System Pharmacists
- Armed Forces Institute of Pathology
- BBC Planning
- Cardinal Health
- CHRISTUS Health
- The Cleveland Clinic Foundation
- Duke University Health System
- Fairview Health Services
- Henry Schein, Inc.
- Inova Health System Foundation
- Johns Hopkins Health System
- Lehigh Valley Health Network
- Mitretek Systems
- Owens & Minor
- Peminic Corporation
- Quest Medical, Inc.
- Roche Diagnostics
- Stericycle Pharmaceutical Services
- Tenet Healthcare Corporation
- US Food and Drug Administration
- US Army Medical Materiel Agency
- Vanderbilt University Medical Center
- The Work Group
Forum Organization
The Forum will consist of an opening session, four working sessions, and
a wrap-up session. Each working session will cover one phase of the recall
process. A panel composed of representatives from the four major stakeholders
in the recall process -- manufacturers, distributors, hospitals, and the
FDA -- will initiate the discussion in each session. They will pinpoint
data and information flow shortcomings in the phase of the process under
discussion and will propose initiatives to address these shortcomings.
The second half of each session will be an open dialogue between the panelists
and audience. The session moderator will begin the dialogue by raising questions
and discussion topics submitted in advance by conference attendees. The
audience will also have an opportunity to raise discussion points that have
not yet been addressed.
A summary of the findings and conclusions in each session will be documented
and presented as part of the wrap-up session. After the conference, Mitretek
will release a report on the findings of the Forum. |
Product alerts, from recall notices to information bulletins,
are a critical part of the U.S. healthcare system. The existing product
alert process suffers from numerous data and information exchange shortcomings.
In addition, the recall process is poorly understood across its entire
life cycle, which has lead to misperceptions about the overall process.
The focus of the Improving the Healthcare Recall Process Forum
will be on identifying the major problems in the product alert process
and the initiatives that should be undertaken to address them.
Improving the Healthcare Recall Process Detailed Agenda
|
| Tuesday, June 13, 2006 |
6:00 PM - 8:00 PM
Networking Reception
Open bar and hors d'oeuvres at Robert's Restaurant & Terrace
at the Omni Shoreham Hotel.
|
Robert's Restaurant
|
| Wednesday, June 14, 2006 |
7:30 AM - 8:30 AM
Continental Breakfast |
Blue Room |
8:30 AM - 9:15 AM
Opening Session
|
Blue Room
|
 Welcoming Remarks
-
The Honorable Togo D. West, Jr., Chairman, Mitretek Systems Board
of Trustees, President and Chief Executive Officer of the Joint Center
for Political and Economic Studies.
Keynote Speaker
- Dr. Richard Davis, Director of Johns Hopkins Center for Patient
Quality and Improvement
Opening Remarks on the Product Recall Process
- Richard Fiddleman, Director of Technology Based Services, Mitretek
Systems
|
9:15 AM - 10:45 AM
Session 1: From Awareness of the Problem to Decision
To Inform
|
- Session Overview - This session covers the phase of the product
alert process from when the manufacturer begins to receive information
about a problem(s) with one of their products until the manufacturer
concludes that a product alert must be issued.
- Speakers:
Claude Grant, Sr. Vice President, Quality and Regulatory
Affairs, Cardinal Health
Kimber Richter, Deputy Director for Medical Affairs,
Office of Compliance, CDRH, FDA
- Panelist:
Mark Vare, RPh, RAC, Consultant, Stericycle Pharmaceutical
Services
|
10:45 AM - 11:00 AM Break
|
11:00 AM - 12:30 PM
Session 2: From Decision To Inform to Informing the
Industry
|
- Session Overview - This session covers the phase of the product
alert process during which the manufacturer releases product alerts
to their product users, distributors, the FDA, and other 3rd party re-publishers
of the alert.
- Speaker:
Cap Uldriks, Special Assistant to the Director
of the Office of Compliance, CDRH, FDA
Claude Grant, Senior Vice President, Quality and
Regulatory Affairs, Cardinal Health
|
12:30 PM - 1:15 PM Lunch
|
Prefunction Blue Room
|
1:15 PM - 2:45 PM
Session 3: From Informing the Industry to Completing
Actions at the Healthcare Delivery Organization
|
Blue Room
|
- Session Overview - This session covers hospital activities
from learning about a new product alert to completing their activities
in reacting to the alert.
- Speaker:
Jane Pleasants, Assistant VP for Procurement and
Supply Chain Management, Duke University
Claude Grant, Senior Vice President, Quality and
Regulatory Affairs, Cardinal Health
- Panelists:
Kimber Richter, Deputy Director for Medical Affairs, Office of Compliance, CDRH, FDA
Mike Personett, Senior Vice President of Product Management,
Peminic Corporation
|
2:45 PM - 3:00 PM Break
|
3:00 PM - 4:30 PM
Session 4: From Completing Actions at the Healthcare
Delivery Organization to Alert Completion
|
- Session Overview - This session covers the flow of information
about the results of a recall back to the manufacturer and the flow
of reimbursement information from the manufacturer to the hospital or
distributor.
- Speakers:
Cindy Kilgore, AVP Materials Management, Inova
Health System
Mark Vare, RPh, RAC, Consultant, Stericycle Pharmaceutical
Services
Claude Grant, Senior Vice President, Quality and
Regulatory Affairs, Cardinal Health
- Panelists:
Michael J. Verdi Senior Recall Coordinator, CDRH
Recall Team, FDA
|
4:30 PM - 5:30 PM
Conclusion
|
 Next
Steps Discussion
Closing Remarks
- Lydia Waters Thomas, Ph.D. - President and Chief Executive
Officer, Mitretek Systems
|
5:30 PM- 7:30 PM Dinner Buffet
Open bar and buffet dinner in the Omni Hotel's Hampton Room.
|
Hampton Room
|
