CBER Encourages Industry Participation in Training Program

April 13, 2006
Pharmaceutical Technology Editors

The US Food and Drug Administration's Center for Biologics Evaluation and Research (CBER) is again extending an invitation to biologics facilities for participation in its Regulatory Site Visit Training Program (RSVP). The program, initiated in 2005, aims to give CBER's regulatory review, compliance, and other relevant staff an opportunity to visit biologics facilities and allow CBER staff to directly observe routine manufacturing practices. The objective is to give its staff a better understanding of the biologics industry, including its challenges and operations, and improve communication with CBER staff and industry.

The US Food and Drug Administration's (Rockville, MD, www.fda.gov) Center for Biologics Evaluation and Research (CBER) is again extending an invitation to biologics facilities for participation in its Regulatory Site Visit Training Program (RSVP). The program, initiated in 2005, aims to give CBER's regulatory review, compliance, and other relevant staff an opportunity to visit biologics facilities and to allow CBER staff to observe routine manufacturing practices directly. The objective is to give its staff a better understanding of the biologics industry, including its challenges and operations, and to improve communication with CBER staff and industry.

In this program, over a period of time agreed upon with the facility, small groups of CBER staff observe operations of biologics establishments, including packaging facilities, quality control and pathology/toxicology laboratories, and regulatory affairs operations. CBER assures that these visits, or any part of the program, are not intended as a mechanism to inspect, assess, judge, or perform a regulatory function, but are meant to improve mutual understanding and to provide an avenue for open dialog between the biologics industry and CBER.

Biologics facilities wishing to participate in RSVP, offer a site visit, or learn more about this training opportunity for CBER staff should submit a request to participate to the Division of Dockets Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane, Rm 1061, Rockville, MD 20852. Electronic requests may be submitted to www.fda.gov/dockets/ecomments.

Biologics facilities that have applied previously and are interested in participating in this year's program, should notify CBER of their continued interest by sending an e-mail to matt@cber.fda.hhs.gov.

All requests must be submitted by May 11, 2006.

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