[Federal Register Volume 69, Number 71 (Tuesday, April 13, 2004)]
[Notices]
[Page 19435]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 04-8251]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration


Fifth Joint Project Management Workshop on Improving Agency/
Industry Communication Throughout the Drug Development Process; Public 
Workshop

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice of public workshop.

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    The Food and Drug Administration (FDA) in cosponsorship with the 
Drug Information Association (DIA) is announcing a public workshop 
entitled ``The Fifth Joint Project Management Workshop: Improve Agency/
Industry Communication Throughout the Drug Development Process.'' The 
workshop will focus on facilitating the drug development and drug 
review processes through interactions between industry and FDA to 
effectively manage risk to expedite products of public benefit to 
market.
    Date and Time: The public workshop will be held on May 11, 2004, 
from 8:30 a.m. to 5 p.m., May 12, 2004, from 8:30 a.m. to 5 p.m., and 
May 13, 2004, from 8:30 a.m. to 12:30 p.m.
    Location: The public workshop will be at the Hyatt Regency 
Bethesda, 1 Bethesda Metro Center, Bethesda, MD.
    Contact Person: Julieann Dubeau, Center for Drug Evaluation and 
Research (HFD-180), Food and Drug Administration, 5600 Fishers Lane, 
Rockville, MD, 301-827-7310, FAX: 301-827-1305, 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, 800 Enterprise Rd., suite 200, Horsham, PA 19044, 215-442-
6196, FAX: 215-442-6103, e-mail: [email protected].
    Registration: Mail or fax your registration information and 
registration fee to Drug Information Association (DIA), P.O. Box 
827192, Philadelphia, PA 19182-7192. You may obtain registration forms 
from DIA (see Contact Person) 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. (FDA has verified the Web site, but we are 
not responsible for subsequent changes to the Web site after this 
document publishes in the Federal Register.)
    If you need special accommodations due to a disability, please 
contact Camela Pastorius (see Contact Person) by May 4, 2004.

SUPPLEMENTARY INFORMATION: FDA (the Center for Biologics Evaluation and 
Research and the Center for Drug Evaluation and Research) and DIA are 
cosponsoring a public 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 project directors, leaders, 
managers, and regulatory affairs representatives from industry; and FDA 
reviewers, regulatory project managers, and consumer safety officers. 
At the conclusion of the workshop, the participants should be able to 
do the following: (1) Identify FDA/industry cultural differences that 
influence interactions between the two groups, (2) effectively manage 
constructive interactions in a changing environment, and (3) manage 
communication strategies for facilitating drug approvals.

    Dated: April 6, 2004.
Jeffrey Shuren,
Assistant Commissioner for Policy.
[FR Doc. 04-8251 Filed 4-12-04; 8:45 am]
BILLING CODE 4160-01-S