[Federal Register Volume 64, Number 212 (Wednesday, November 3, 1999)]
[Notices]
[Page 59779]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 99-28564]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
Training Programs 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) is initiating of two
new training programs: The Regulatory Project Manager Site Tours and
the Regulatory Project Manager Shadowing Program. These programs are
intended to give the Center for Drug Evaluation and Research's (CDER's)
regulatory project managers an opportunity to tour pharmaceutical
facilities and shadow their industry counterparts. Both the tour and
shadowing programs are intended to enhance review efficiency and
quality by providing CDER staff with a better understanding of the
pharmaceutical industry and its operations. The purpose of this notice
is to invite pharmaceutical companies interested in participating in
these programs to contact CDER for more information.
DATES: Pharmaceutical companies may request training program
information at any time.
FOR FURTHER INFORMATION CONTACT: Deborah L. Kallgren, Center for Drug
Evaluation and Research (HFD-2), Food and Drug Administration, 5600
Fishers Lane, Rockville, MD 20857, 301-594-5481, FAX 301-827-3132.
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 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 initiating two new training
programs to give regulatory project managers the opportunity to tour
pharmaceutical facilities and shadow their industry regulatory/project
management counterparts. The goals are: (1) To provide first hand
exposure to industry's drug development processes, and (2) to provide a
venue for sharing information about project management procedures (but
not drug-specific information) with industry representatives.
II. The Project Manager Site Tours and Regulatory Project Manager
Shadowing Program
A. Regulatory Project Management Site Tours
In this program, over a 2-day period, small groups (six or less)
of project managers accompanied by a senior level regulatory project
manager may observe operations of pharmaceutical manufacturing,
packaging facilities and pathology/toxicology laboratories, and
regulatory affairs operations. The purpose of this tour, or any part of
the program, is meant to improve mutual understanding and to provide an
avenue for open dialogue.
B. Regulatory Project Manager Shadowing Program
In this program, over a 2- to 3-day visit, regulatory project
managers will accompany their industry counterparts in their day-to-day
activities. The primary objective of the shadowing program is to learn
about the team approach to drug development, including drug discovery,
preclinical evaluation, project tracking mechanisms, and regulatory
submission operations. The overall benefit to regulatory project
managers will be exposure to project management and team techniques and
processes employed by the pharmaceutical industry, professional and
personal growth, and enhanced job satisfaction and performance through
increased understanding of the industry processes and procedures that
directly relate to their jobs.
C. Site Selection
All travel expenses associated with the site tours and/or
shadowing programs will be the responsibility of CDER, therefore,
selection of potential facilities will be based on available resources
for this program.
If your firm is interested in learning more about these training
opportunities, please contact Deborah L. Kallgren (address above).
Dated: October 25, 1999.
Margaret M. Dotzel,
Acting Associate Commissioner for Policy.
[FR Doc. 99-28564 Filed 11-2-99; 8:45 am]
BILLING CODE 4160-01-F
