69 FR 71 pg. 19435 - Fifth Joint Project Management Workshop on ImprovingAgency/Industry Communication Throughout the Drug Development Process;Public Workshop
Type: NOTICEVolume: 69Number: 71Page: 19435
FR document: [FR Doc. 04-8251 Filed 4-12-04; 8:45 am]
Agency: Health and Human Services Department
Sub Agency: Food and Drug Administration
Official PDF Version: PDF Version
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
Fifth Joint Project Management Workshop on ImprovingAgency/Industry Communication Throughout the Drug Development Process;Public Workshop
AGENCY:
Food and Drug Administration, HHS.
ACTION:
Notice of public workshop.
The Food and Drug Administration (FDA) in cosponsorship with the DrugInformation Association (DIA) is announcing a public workshop entitled"The Fifth Joint Project Management Workshop: ImproveAgency/Industry Communication Throughout the Drug DevelopmentProcess." The workshop will focus on facilitating the drugdevelopment and drug review processes through interactions between industryand FDA to effectively manage risk to expedite products of public benefitto market.
Date and Time : The public workshop will be held on May11, 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 HyattRegency Bethesda, 1 Bethesda Metro Center, Bethesda, MD.
Contact Person : Julieann Dubeau, Center for DrugEvaluation and Research (HFD-180), Food and Drug Administration,5600 Fishers Lane, Rockville, MD, 301-827-7310, FAX:301-827-1305, e-mail: Dubeau@cder.fda.gov , orGail 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: Sherman@cber.fda.gov , or Camela Pastorius, Drug InformationAssociation, 800 Enterprise Rd., suite 200, Horsham, PA 19044,215-442-6196, FAX: 215-442-6103, e-mail: Camela.Pastorius@diahome.org .
Registration : Mail or fax your registration informationand registration fee to Drug Information Association (DIA), P.O. Box827192, Philadelphia, PA 19182-7192. You may obtain registrationforms from DIA (see Contact Person ) or from FDA at http://www.fda.gov/cber/meetings.htm . Additional informationregarding 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 subsequentchanges to the Web site after this document publishes in the Federal Register .)
If you need special accommodations due to a disability, please contactCamela Pastorius (see Contact Person ) by May 4,2004.
SUPPLEMENTARY INFORMATION:
FDA (the Center forBiologics Evaluation and Research and the Center for Drug Evaluation andResearch) and DIA are cosponsoring a public workshop as part of acontinuing effort to develop higher levels of teamwork, communication, andprocedural knowledge to facilitate drug development and review in theUnited 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 safetyofficers. At the conclusion of the workshop, the participants should beable to do the following: (1) Identify FDA/industry cultural differencesthat influence interactions between the two groups, (2) effectively manageconstructive interactions in a changing environment, and (3) managecommunication 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]
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