[Federal Register: October 23, 2003 (Volume 68, Number 205)]
[Page 60701-60702]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]



Food and Drug Administration

[Docket No. 2003N-0455]

Training Program for Regulatory Project Managers; Information 
Available to Industry

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.


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. This training program was initiated in 1999, and it is 
intended to give CDER regulatory project managers an opportunity to 
tour pharmaceutical facilities and to exchange regulatory experiences 
with their industry counterparts. The Site Tours Program is intended to 
enhance review efficiency and quality by providing CDER staff with a 
better understanding of the pharmaceutical industry and its operations. 
Further, this program is intended 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 to the 
agency on or before December 22, 2003.

FOR FURTHER INFORMATION CONTACT: Patricia A. Stewart, Center for Drug 
Evaluation and Research (HFD-160), Food and Drug Administration, 5600 
Fishers Lane, Rockville, MD 20857, 301-827-7496, FAX 301-480-6036.


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, the 
center has initiated

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various training and development programs to promote high performance 
of 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 this training program to 
give regulatory project managers the opportunity to tour pharmaceutical 
facilities. The goals are to provide: (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. Regulatory Project Management Site Tours and Regulatory Interaction 

    In this program, over a 2- to 3-day period, small groups (five or 
less) of regulatory project managers, accompanied by a senior level 
regulatory project manager, may observe operations of pharmaceutical 
manufacturing, 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, project tracking mechanisms, and regulatory submission 
    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.
    If your firm is interested in offering a site tour or learning more 
about this training opportunity, please respond within 60 days of this 
notice by submitting a proposed agenda to Patricia A. Stewart (see FOR 

    Dated: October 14, 2003.
Jeffrey Shuren,
Assistant Commissioner for Policy.
[FR Doc. 03-26695 Filed 10-22-03; 8:45 am]