Expansion of Electronic Submissions Gateway Lot Release Pilot

Expansion of Electronic Submissions Gateway Lot Release PilotFurther expand the electronic lot release program. A randomized sampling of biological product manufacturers subject to lot release will be invited to participate in the electronic submission of their lot release protocols, and will be instructed in preparation of the electronic protocols.In the effort to optimize lot release efficiency to get the much needed 2009 H1N1 influenza virus vaccine out to the public in a timelier manner, OCBQ piloted an electronic lot release submission program. Due to the pilot’s success, OCBQ decided to implement the new system for all 2010-2011 seasonal flu vaccine lot releases. During the current project, OCBQ developed and implemented the initial phase of an expansion plan to offer electronic submission for all products subject to lot release so biologic products can reach the public more efficiently and effectively.

A. Randomization of firms for first phase of electronic lot release expansion

1/14/2011

Completed

1/10/2011

B. Process map and instructions for electronic lot release expansion

2/28/2011

Completed

2/28/2011

C. Implement first phase of electronic lot release expansion

4/15/2011

Completed

4/13/2011

D. Evaluation of results of first phase of electronic lot release expansion

8/31/2011

Completed

8/26/2011

Molecular EpidemiologyMolecular epidemiology is a branch of medical science that focuses on the contribution of potential genetic and environmental risk factors, identified at the molecular level, to the etiology, distribution and prevention of disease within families and across populations.

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