[Federal Register Volume 67, Number 144 (Friday, July 26, 2002)]
[Notices]
[Page 48921]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 02-19019]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration


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 Manager Site Tours. This training program, initiated 
in 1999, gives CDER's regulatory project managers an opportunity to 
tour pharmaceutical facilities. The program provides regulatory project 
managers and their industry counterparts an opportunity to share their 
regulatory experiences. The program is intended to enhance review 
efficiency and quality by providing CDER staff with a better 
understanding of the pharmaceutical industry and its operation, and to 
improve communication and cooperation between CDER staff and industry. 
The purpose of this notice is to invite pharmaceutical companies 
interested in participating in these programs to contact CDER.

DATES:  Pharmaceutical companies may submit proposed agendas by 
September 9, 2002.

FOR FURTHER INFORMATION CONTACT: Sean J. Belouin, Center for Drug 
Evaluation and Research (HFD-530), Food and Drug Administration, 5600 
Fishers Lane, Rockville, MD 20857, 301-827-2481, FAX 301-827-2523, 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 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 the Regulatory 
Project Manager Site Tours to give regulatory project managers the 
opportunity to tour pharmaceutical facilities. The goals are to 
provide: (1) Firsthand 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. Regulatory Project Manager Site Tours and Regulatory 
Interactions

    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, may observe operations of pharmaceutical 
manufacturing, packaging facilities, 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.
    During the site tours, regulatory project managers and their 
industry counterparts will also participate in daily workshops 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, project 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 of potential facilities 
will be based on available resources for this program.
    If your firm is interested in offering a site tour or learning more 
about this training opportunity, please submit a proposed agenda to 
Sean J. Belouin (see FOR FURTHER INFORMATION CONTACT).

    Dated: July 17, 2002.
Margaret M. Dotzel,
 Associate Commissioner for Policy.
[FR Doc. 02-19019 Filed 7-25-02; 8:45 am]
BILLING CODE 4160-01-S