[Federal Register Volume 63, Number 165 (Wednesday, August 26, 1998)]
[Notices]
[Page 45511]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 98-22927]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration


Bioresearch Monitoring: Public Workshop

AGENCY:  Food and Drug Administration, HHS.

ACTION:  Notice of public workshop.

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    The Food and Drug Administration (FDA) Office of Regulatory 
Affairs, Nashville District Office is announcing the following public 
workshop: Bioresearch Monitoring: Public Workshop. The workshop is 
being co-sponsored by Vanderbilt University Medical Center and Meharry 
Medical College, both of Nashville, TN. Topics to be discussed are FDA 
regulatory requirements for the conduct of investigational product 
research and practical issues, such as, how to prepare for a data 
audit, what to expect during an inspection, and how to get current 
information from FDA.
    Date and Time:  The workshop will be held on Thursday and Friday, 
September 17 and 18, 1998, from 8:30 a.m. to 5 p.m. each day.
    Location:  The workshop will be held at Vanderbilt University 
Medical Center, Light Hall, Nashville, TN 37232. Maps and further 
information may be obtained from the contact person or the registrar 
(listed below).
    Contact:  Sandra S. Baxter, Public Affairs Specialist, Nashville 
District Office, Food and Drug Administration, 297 Plus Park Blvd., 
Nashville, TN 37217, at 615-781-5385 ext. 122., FAX 615-781-5383.
    Registration: Send registration information (including name, title, 
firm name, address, telephone, and fax number), to the Institutional 
Review Board at 615-322-2918 or FAX 615-343-2648 or e-mail to 
``[email protected]'' by September 10, 1998. Attendance will be 
limited to the first 300 applicants, therefore, interested parties are 
encouraged to register early.
    A $25.00 registration fee is being charged by Vanderbilt University 
Medical Center to cover cost of materials, box lunches, and beverages 
for breaks.
    If you need special accommodations due to a disability, please 
contact Sandra S. Baxter (fax number above) at least 7 days in advance.
SUPPLEMENTARY INFORMATION: FDA's survey of the bioresearch industry 
shows that many of these firms are either unaware of applicable 
regulations and guidelines or not in compliance with applicable 
requirements. The workshop is designed to assist the industry in 
complying with regulations for clinical investigators, institutional 
review boards and sponsor-monitors; and to promote and encourage open 
dialogue between FDA and professionals involved in investigational 
product research: Physicians, researchers, research coordinators, 
nurses, allied health professionals, and other interested parties. In 
addition, break out sessions will be available on new and emerging 
issues.

    Dated: August 20, 1998.
William K. Hubbard,
Associate Commissioner for Policy Coordination.
[FR Doc. 98-22927 Filed 8-25-98; 8:45 am]
BILLING CODE 4160-01-F