[Federal Register Volume 67, Number 69 (Wednesday, April 10, 2002)]
[Notices]
[Page 17434]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 02-8612]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration


Drug Information Association and Food and Drug Administration on 
the Fourth Project Management Workshop: Effective Agency/Industry 
Interactions to Expedite Drug Development; Public Workshop

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice of public workshop.

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SUMMARY: The Food and Drug Administration (FDA) in cosponsorship with 
the Drug Information Association (DIA) is announcing a public workshop 
entitled ``The Fourth Project Management Workshop: Effective Agency/
Industry Interactions to Expedite Drug Development.'' The workshop will 
focus on facilitating drug development and drug review processes.
    Date and Time: The workshop will be held on April 30, 2002, from 
8:30 a.m. to 5 p.m., May 1, 2002, from 8:30 a.m. to 5 p.m., and May 2, 
2002, from 8:30 a.m. to 12:30 p.m.
    Location: The workshop will be at the Hyatt Regency Bethesda, 1 
Bethesda Metro Center, Bethesda, MD.
    Contacts: For information about this notice: Michael D. Anderson, 
Center for Biologics Evaluation and Research (CBER) (HFM-17), Food and 
Drug Administration, 1401 Rockville Pike, Rockville, MD 20852, 301-827-
6210, FAX 301-594-1944, e-mail: [email protected].
    For information about the workshop: David Roeder, Center for Drug 
Evaluation and Research (CDER) (HFD-104), Food and Drug Administration, 
9201 Corporate Blvd. Rockville, MD 20850, 301-827-2488, FAX 301-827-
2520, e-mail: [email protected], or Gail Sherman, Center for 
Biologics Evaluation and Research (HFM-42), Food and Drug 
Administration, 1401 Rockville Pike, Rockville, MD 20852, 301-827-2000, 
FAX 301-827-3079, e-mail: [email protected], or Camela Pastorius, 
Drug Information Association (DIA), 501 Office Center Dr., suite 450, 
Fort Washington, PA 19034, 215-591-3303, FAX 215-641-1229, e-mail: 
[email protected]. If you need special accommodations due to 
a disability, please contact Camela Pastorius (address above) by April 
23, 2002.
    Registration: Mail or fax your registration information and 
registration fee to DIA, P.O. Box 7777-W8405, Philadelphia, PA 19175. 
You may obtain registration forms from DIA (see contact information) or 
from FDA at http://www.fda/gov/cber/meetings.htm. Additional 
information regarding registration fees and online registration can be 
found at http:/www.diahome.org/docs/Events/Events_search_detail.cfm?EventID=0201.

SUPPLEMENTARY INFORMATION: FDA (CBER and CDER) and DIA are cosponsoring 
a workshop as part of a continuing effort to develop higher levels of 
teamwork, communication, and procedural knowledge to facilitate drug 
development and review in the United States. The workshop's target 
audience is FDA regulatory project managers and pharmaceutical industry 
project management and regulatory teams who have mid-level experience 
and are involved in daily agency-industry interactions.
    The workshop will present three major themes:
     Planning and Teamwork--attendees will participate in 
activities designed to highlight the value of teamwork, and to exchange 
ideas about team organization and management;
     Understanding the Process of Regulatory Project 
Management--the workshop will explore parallel objectives and 
activities within industry and FDA and identify opportunities for 
effective interaction. Attendees will also share ideas for optimizing 
working relationships between project management and regulatory 
professionals and between industry representatives and FDA regulatory 
project managers;
     Key Factors for Success--the workshop will present a set 
of experience-based factors for successful FDA/industry interaction.

    Dated: April 4, 2002.
Margaret M. Dotzel,
Associate Commissioner for Policy.
[FR Doc. 02-8612 Filed 4-9-02; 8:45 am]
BILLING CODE 4160-01-S