Notice2024-03039
Training Program for Regulatory Project Managers; Information Available to Industry
Primary source
Metadata and text below are from the Federal Register, a public-domain U.S. government work. Always verify the official published version before relying on it for any legal matter.
Published
February 14, 2024
Issuing agencies
Health and Human Services DepartmentFood and Drug Administration
Abstract
The Food and Drug Administration's (FDA or the Agency) 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.
Full Text
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<title>Federal Register, Volume 89 Issue 31 (Wednesday, February 14, 2024)</title>
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[Federal Register Volume 89, Number 31 (Wednesday, February 14, 2024)]
[Notices]
[Pages 11302-11303]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[FR Doc No: 2024-03039]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2014-N-0179]
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's (FDA or the Agency) 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 send proposed agendas to the Agency
by April 15, 2024.
FOR FURTHER INFORMATION CONTACT: Dan Brum, Center for Drug Evaluation
and Research, Food and Drug Administration, 10903 New Hampshire Ave.,
Bldg. 22, Rm. 5480, Silver Spring, MD 20993-0002, 301-796-0578,
<a href="/cdn-cgi/l/email-protection#b2f6d3dc9cf0c0c7dff2d4d6d39cdadac19cd5ddc4"><span class="__cf_email__" data-cfemail="46022728680434332b06202227682e2e3568212930">[email protected]</span></a>.
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 goal, CDER has
initiated various training and development programs to promote high
performance in its regulatory project management staff. CDER seeks to
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) 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. The Site Tours Program
In this program, which generally lasts a few days, small groups of
CDER regulatory project managers, often 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
[[Page 11303]]
daily workshops is to learn about the team approach to drug
development, including drug discovery, nonclinical and clinical
evaluation, postmarketing activities, 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 Program will be
the responsibility of CDER; therefore, selection will be based on the
availability of funds and resources for each fiscal year. Selection
will also be based on firms having a favorable facility status as
determined by FDA's Office of Regulatory Affairs District Offices in
the firms' respective regions. Firms that want to learn more about this
training opportunity or that are interested in offering a site tour
should respond by sending a proposed agenda by email directly to Dan
Brum (see DATES and FOR FURTHER INFORMATION CONTACT).
Dated: February 9, 2024.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2024-03039 Filed 2-13-24; 8:45 am]
BILLING CODE 4164-01-P
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