Meetings: Bioresearch monitoring; workshop,
[Federal Register: August 26, 1998 (Volume 63, Number 165)]
[Notices]
[Page 45511]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr26au98-70]
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.
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 ``IRB@mcmail.vanderbilt.edu'' 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. 98-22927Filed8-25-98; 8:45 am]
BILLING CODE 4160-01-F
