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U.S. Department of Health and Human Services

About FDA

CBER Participation in CBER Liaison and Roundtable Meetings with Industry

Description: CBER holds recurring liaison and roundtable meetings with outside organization to provide an opportunity to discuss topics of mutual interest and for outside concerns to be expressed, as well as to provide information on CBER’s operations. OCOD serves in a coordinating role by scheduling and documenting liaison and roundtable meetings with industry, trade associations and consumer organizations. This key project will be to evaluate these meetings and determine what, if any, changes need to be made to the program.

Accomplishment: The Center for Biologics Evaluation and Research (CBER) has a policy to meet with external industry organizations on a recurring basis. These meetings (termed “liaison meetings”) are intended to provide an opportunity for stakeholder input, as well as to provide information on CBER’s operations. When the policy was put into place in the late 1990s, CBER was only meeting with a handful of industry organizations. Over the years that number has increased dramatically. Meeting with each of these groups twice yearly required a great deal of resources from the participating offices – planning logistics, meeting preparation and meeting participation – and involved high level participants, often from several offices and the Office of the Director. After discussing with Center leadership, OCOD developed an FDA TRACK key project to determine if any changes needed to be made to the liaison meeting policy. OCOD carefully reviewed the policy as well as meeting minutes and topics covered for all meetings conducted over the last 15+ years, where information was available. OCOD then surveyed staff from across CBER who participate in liaison meetings in one capacity or another. Survey participants were asked a series of questions about these meetings, including questions on time investment, resources, and usefulness of meetings. The majority of participants found the meetings useful, but agreed that changes to the program were needed in order to deal with the current volume of requests from industry. As a result, OCOD, in conjunction with the participating offices and the Office of the Director, made a change to the liaison meeting policy to hold meetings once per year with each organization, rather than twice yearly. In addition, a second, “executive-level” meeting option was added to the policy, which industry organizations could request annually. These meetings, which are intended to be limited to senior leadership from CBER and the requesting organization, are shorter in length and focused on high-level areas of interest. It is expected that not all organizations will take advantage of requesting an executive level meeting each year, thereby reducing the overall number of meetings CBER staff participate in. OCOD announced this policy change to industry organizations in writing, and updated the liaison meeting SOPP. The change has been generally well-received by industry, with several requests for executive level meetings received to date.

Briefing Status: Completed

Prior Briefing Status: DELAYED

Milestone DescriptionMilestone DateMilestone StatusMilestone Completion Date

A. Contact CBER Program Offices to identify the organizations for liaison and roundtable meetings each plans to support during the calendar year.

2/15/2012

Completed 1/15/2012

B. Develop survey to solicit feedback from CBER Program Offices regarding the liaison/roundtable meeting program.

9/15/2012

Completed 9/15/2012

C. Processing of liaison meeting requests: Capture the number of internal pre-meetings and external liaison/roundtable meetings scheduled during the quarters: 4/5/2012 (1), 7/5/2012, 10/5/2012, and 1/5/2013

1/5/2013

Completed 1/30/2013

D. Upon completion of liaison/roundtable meetings for the calendar year, administer survey to CBER Program Offices regarding resources spent, time, value of meeting discussions.

1/15/2013

Completed 6/14/2013

E. Evaluate survey results and prepare report for CBER Office Directors with recommendations for potential changes to program (2).

3/1/2013

Completed 7/18/2014

F. Program or SOPP revisions based on evaluations results (2).

5/1/2013

Completed 1/15/2015

Footnotes

  • (1) There have been 3 internal pre-meetings and 0 external liaison/roundtable meetings during the first quarter of calendar year 2012.
  • (2) The date for milestone F was adjusted as the due date for milestones D and E were missed.The milestone status reflects the current reporting quarter’s status. If a milestone is missed, the milestone will remain delayed until the milestone is completed.

Key Projects Legend

Milestone StatusDefinition
Not Yet StartedWork for specific milestone has not yet been started.
CompletedMilestone and/or overall project is completed.
On TrackMilestone - On track for completion by milestone deadline. Quarter status - Project is on track for completion based on overall milestone status.
On HoldMilestone - On hold, but deadline for completion has not passed. Quarter status - Project is on hold, based on overall milestone status.
DelayedMilestone - Delayed as it has not been completed and deadline has passed. Quarter status - Project is delayed based on overall milestone status.

Glossary

Note: The data provided on this website is produced on an ongoing basis for performance management purposes and is subject to change due to updates of preliminary estimates, corrections, or other reasons. In addition, FDA may change the type or amount of data provided on this website at any time. Information marked as "Completed" may include measures and/or key projects for which activities are ongoing but no longer tracked as part of FDA-TRACK.