[Federal Register: March 26, 1999 (Volume 64, Number 58)]
[Notices]               
[Page 14735]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr26mr99-115]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

 
Changing Times; Clinical Trial Regulations

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice of meeting.

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    The Food and Drug Administration (FDA), Southeast Region, is 
announcing the following meeting: ``Changing Times: Clinical Trial 
Regulations, Clinical Investigators and IRB's Learning to Cope.'' The 
topic to be discussed is FDA regulatory requirements for the conduct of 
clinical studies and practical issues such as how clinical 
investigators and Institutional Review Boards can cope with the 
regulatory process, 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 meeting will be held on Friday, April 30, 1999, 
from 8 a.m. to 6 p.m.
    Location: The meeting will be held at the Veterans Administration 
Medical Center Auditorium (2d floor), 1201 NW. 25th St., Miami, FL 
33125.
    Contact: Luz I. Collado, Food and Drug Administration, HFR-SE2575, 
P.O. Box 59-2256, Miami, FL 33159, 305-526-2800, ext. 926, or Brunilda 
Torres, Food and Drug Administration, Florida District, HFR-SE250, 407-
475-4718, FAX 407-475-4768.
    Registration: Send registration information (including name, title, 
firm name, address, telephone, and fax number) to Gloria Allington, 
Director, University of Miami School of Medicine, Division of 
Continuing Medical Education, 1500 NW. 12th Ave., Miami, FL 33136, 305-
243-6716, FAX 305-243-5613. Attendance will be limited to the first 200 
applicants, therefore, interested parties are encouraged to register 
early. A $100 registration fee is being charged by the University of 
Miami School of Medicine to help cover costs of materials, breakfast, 
box lunches, and beverages for breaks. A discounted registration fee of 
$90 is being offered to those who register by Thursday, April 1, 1999.
    If you need special accommodations due to a disability, please 
contact Gustavo Godoy, Executive Director and Administrative Officer 
for R&D, VA Medical Center, 1201 NW. 16th St., Miami, FL 33125, 305-
324-3179, FAX 305-324-3126, at least 7 days in advance.

    Dated: March 19, 1999.
 William K. Hubbard,
 Acting Deputy Commissioner for Policy.
[FR Doc. 99-7361 Filed 3-25-99; 8:45 am]
BILLING CODE 4160-01-F