Medical Devices
Public Workshop - Post Approval Studies 2012 Workshop: Design, Methodology, and Role in Evidence Appraisal throughout the Total Product Life Cycle, August 30, 2012
The Food and Drug Administration (FDA) is announcing the following public workshop entitled Post Approval Studies 2012 Workshop: “Design, Methodology, and Role in Evidence Appraisal throughout the Total Product Life Cycle.” The topics of discussion will include the following: post-approval studies in the Total Product Life Cycle, best practices and improvement of implementation strategies for post-approval studies, public health impact and innovative methodologies for evidence appraisal. FDA is holding this public workshop to provide update and obtain stakeholders input on Post-Approval Studies ordered at the time of device approval.
Date, Time and Location
This workshop will be held August 30, 2012, beginning at 8:00 am at the following location:
FDA White Oak Campus
10903 New Hampshire Avenue
Building 31 Conference Center (Great Room, Room 1503)
Silver Spring, MD 20993
The workshop will be webcasted.
Webcast
An online archive of the webcast for this event is available:
Agenda
| Time | Topic | Speakers | |
|---|---|---|---|
| 8:00-8:05 | Call for Order and Introductions | Nilsa Loyo-Berríos, FDA | |
| 8:05-8:15 | Welcome and Goals for the Day | Danica Marinac-Dabic, FDA | |
| 8:15-8:30 | Welcome Remarks and Perspective on Post-Approval Studies | Thomas Gross, FDA | |
| Session I: PAS in the Total Product Life Cycle | |||
| 8:30-8:40 | PAS Program Overview | Nilsa Loyo-Berríos, FDA | |
| 8:40-8:50 | Premarket Factors Leading to PAS Questions | Randall Brockman, FDA | |
| 8:50-9:00 | Use of PAS Data Throughout Device Life-Cycle | Daniel Caños, FDA | |
| 9:00-9:15 | New Postmarket Initiatives and the PAS Program | Danica Marinac-Dabic, FDA | |
| 9:15-10:00 | Panel Discussion | ||
| 10:00-10:10 | Break | ||
| Session II: Best Practices and Improvement of PAS Implementation Strategies | |||
| 10:10-10:20 | FDA Perspective on Opportunities for PAS Studies Implementation | Veronica Sansing, FDA | |
| 10:20-10:30 | Industry Perspective on Opportunities for PAS Studies Implementation | Roberta Dressen, Medtronic | |
| 10:30-10:40 | Innovative Methodologies, Data Sources and Leveraging Existing Infrastructure | Sharon-Lise Normand, Harvard University | |
| 10:40-10:50 | Use of International Infrastructure and Data | Art Sedrakyan, Cornell University | |
| 10:50-11:00 | Best Practices and the Role of Partnerships | David Naftel, University of Alabama at Birmingham | |
| 11:00-11:45 | Panel Discussion | ||
| 11:45-12:00 | Small Group Discussions – Background | Mary Beth Ritchey, FDA | |
| 12:00-1:00 | Lunch | ||
| Session III: PAS Impact on Public Health and Medical Device Innovation | |||
| 1:00-2:00 | Small Group Discussion: PAS Impact on Public Health | ||
| Small Group Discussion: PAS Program and Medical Device Innovation | |||
| 2:00-2:20 | Break | ||
| 2:20-2:45 | Small Groups Summary Reports (5 minutes each) | ||
| Session IV: Opportunities for Innovative use of PAS Data | |||
| 2:45-3:00 | Improving Trial Design: FDA Perspective on using PAS Data for Bayesian Priors, Historical Controls, OPC, etc. | Laura Thompson, FDA | |
| 3:00-3:15 | Innovative Approaches to Evaluate Rare Outcomes in PAS | JoAnn Kuhne, Sientra | |
| 3:15-3:30 | Academia, Research, MDEpiNet Perspective: PAS as Part of Larger Study | Douglas Packer, Mayo Clinic | |
| 3:30-3:45 | Patient Advocate Perspective: PAS Data to Support Health Care Decision Making | Marlena Vega, Patient Representative | |
| 3:45-4:00 | CMS Perspective: Reimbursement Decisions and Collaborative Review | Jyme Schafer, CMS/OCSQ | |
| 4:00-4:45 | Panel Discussion | ||
| Wrap-up: Moving Forward and Next Steps | |||
| 4:45-5:00 | Vision for the Future of PAS Program | Danica Marinac-Dabic, FDA | |
| 5:00 | Adjourn | ||
Registration
As of August 28, online registration is closed.
There is no fee to register for the workshop and registration will be on a first-come, first-served basis. Early registration is recommended because seating is limited.
If you require special accommodations due to a disability, or need additional information regarding registration, please contact Cindy Garris, Office of Communications, Education, and Radiation Programs, Center for Devices and Radiological Health, Food and Drug Administration, 10903 New Hampshire Avenue, Bldg. 66, Silver Spring, MD 20993, 301-796-5861, FAX: 301-847-8142, Cynthia.garris@fda.hhs.gov.
Transcript
Contact Us
For questions regarding workshop content please contact:
Nilsa Loyo-Berrios, PhD, MSc
Center for Devices and Radiological Health
Food and Drug Administration,
10903 New Hampshire Ave., WO-66 Rm. 3214
Silver Spring, MD 20993
Phone: (301)796-8528
email: Nilsa.Loyo-Berrios@fda.hhs.gov
or
Danica Marinac-Dabic, MD, PhD
Center for Devices and Radiological Health
Food and Drug Administration
10903 New Hampshire Ave., WO-66 Rm. 4110
Silver Spring, MD 20993
phone: (301)796-6689
email: Danica.Marinac-Dabic@fda.hhs.gov
