[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