[Federal Register Volume 74, Number 2 (Monday, January 5, 2009)]
[Notices]
[Pages 305-306]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: E8-31320]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2008-N-0651]
Training Program for Regulatory Project Managers; Information
Available to Industry
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice.
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SUMMARY: The Food and Drug Administration (FDA) Center for Drug
Evaluation and Research (CDER) is announcing the continuation of the
Regulatory Project Management Site Tours and Regulatory Interaction
Program (the Site Tours Program). The purpose of this document is to
invite pharmaceutical companies interested in participating in this
program to contact CDER.
DATES: Pharmaceutical companies may submit proposed agendas to the
agency by March 6, 2009.
FOR FURTHER INFORMATION CONTACT: Beth Duvall-Miller, Center for Drug
Evaluation and Research, Food and Drug Administration, 10903 New
Hampshire Ave., Bldg. 22, rm. 6466, Silver Spring, MD 20993-0002, 301-
796-0700, e-mail: [email protected].
SUPPLEMENTARY INFORMATION:
I. Background
An important part of CDER's commitment to make safe and effective
drugs available to all Americans is optimizing the efficiency and
quality of the drug review process. To support this primary goal, CDER
has initiated various training and development programs to promote high
performance in its regulatory project management
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staff. CDER seeks to significantly enhance review efficiency and review
quality by providing the staff with a better understanding of the
pharmaceutical industry and its operations. To this end, CDER is
continuing its training program to give regulatory project managers the
opportunity to tour pharmaceutical facilities. The goals are to provide
the following: (1) First hand exposure to industry's drug development
processes and (2) a venue for sharing information about project
management procedures (but not drug-specific information) with industry
representatives.
II. The Site Tours Program
In this program, over a 2- to 3-day period, small groups (five or
less) of regulatory project managers, including a senior level
regulatory project manager, can observe operations of pharmaceutical
manufacturing and/or packaging facilities, pathology/toxicology
laboratories, and regulatory affairs operations. Neither this tour nor
any part of the program is intended as a mechanism to inspect, assess,
judge, or perform a regulatory function, but is meant rather to improve
mutual understanding and to provide an avenue for open dialogue. During
the Site Tours Program, regulatory project managers will also
participate in daily workshops with their industry counterparts,
focusing on selective regulatory issues important to both CDER staff
and industry. The primary objective of the daily workshops is to learn
about the team approach to drug development, including drug discovery,
preclinical evaluation, tracking mechanisms, and regulatory submission
operations.
The overall benefit to regulatory project managers will be exposure
to project management, team techniques, and processes employed by the
pharmaceutical industry. By participating in this program, the
regulatory project manager will grow professionally by gaining a better
understanding of industry processes and procedures.
III. Site Selection
All travel expenses associated with the site tours will be the
responsibility of CDER; therefore, selection will be based on the
availability of funds and resources for each fiscal year. Firms
interested in offering a site tour or learning more about this training
opportunity should respond by (see DATES) by submitting a proposed
agenda to Beth Duvall-Miller (see FOR FURTHER INFORMATION).
Dated: December 22, 2008.
Jeffrey Shuren,
Associate Commissioner for Policy and Planning.
[FR Doc. E8-31320 Filed 1-2-09; 8:45 am]
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