[Federal Register Volume 69, Number 48 (Thursday, March 11, 2004)]
[Notices]
[Pages 11636-11637]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 04-5489]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration


Industry Exchange Workshop on FDA Clinical Trial Requirements; 
Public Workshop

AGENCY:  Food and Drug Administration, HHS.

ACTION:  Notice of public workshop.

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SUMMARY: The Food and Drug Administration (FDA) Detroit District, in 
cooperation with the Society of Clinical Research Associates, (SoCRA) 
is announcing a workshop on FDA clinical trial statutory and regulatory 
requirements. Topics for discussion include: Pre-IND(investigational 
new drug application) meetings and FDA meeting process, medical device, 
drug and biological product aspects of clinical research, investigator 
initiated research, informed consent requirements, adverse event 
reporting, how FDA conducts bioresearch inspections, ethics in subject 
enrollment, FDA regulation of Institutional Review Boards, FDA and

[[Page 11637]]

confidence in the conduct of clinical research, and what happens after 
the FDA inspection. This 1 1/2-day workshop for the clinical research 
community targets sponsors, monitors, clinical investigators, 
institutional review boards and those who interact with them for the 
purpose of conducting FDA regulated clinical research. The workshop 
will include both industry and FDA perspectives on proper conduct of 
clinical trials regulated by FDA.
    Date and Time: The public workshop is scheduled for Wednesday, 
April 21, 2004 from 8:30 a.m. to 4:45 p.m. and Thursday, April 22, 
2004, from 8:45 a.m. to 12:30 p.m.
    Location: The public workshop will be held at the Livonia, Michigan 
Holiday Inn, 17123 Laurel Park Dr. North, Livonia, MI 48152.
    Contact: Nancy Bellamy, FDA, 300 River Pl., suite 5900, Detroit, MI 
48207, 313-393-8143, FAX: 313-393-8139, e-mail [email protected] or 
Marie Falcone, Industry and Small Business Representative, FDA, rm. 900 
U.S. Customhouse, 200 Chestnut St., Philadelphia, PA 19106, 215-597-
2120, ext. 4003, FAX: 215-597-5798, e-mail: [email protected].
    Registration: Send registration information (including name, title, 
firm name, address, telephone, and fax number) and $485 (member) or 
$560 (non-member) registration fee made payable to SoCRA, P.O. Box 101, 
Furlong, PA 18925. To register via the Internet go to http://www.socra.org/FDA_Conference.htm. FDA has verified the Web site 
address, but is not responsible for subsequent changes to the Web site 
after this document publishes in the Federal Register.
    Registrar will also accept payment by major credit cards. For more 
information on the meeting, or for questions on registration, contact 
800 -SoCRA92 (800-762-7292), or 215-345-7369 or via e-mail to 
[email protected]. Attendees are responsible for their own 
accommodations. To make reservations at the Holiday Inn Livonia at the 
reduced conference rate, contact the Holiday Inn at 734-464-1300 or at 
hotel FAX: 734-464-1596 before March 23, 2004.
    The registration fee will be used to offset the expenses of hosting 
the conference, including meals, refreshments, meeting rooms, and 
materials. Space is limited, therefore interested parties are 
encouraged to register early. Limited onsite registration may be 
available. Please arrive early to ensure prompt registration.
    If you need special accommodations due to a disability, please 
contact Marie Falcone at least 7 days in advance of the workshop.

SUPPLEMENTARY INFORMATION: The ``FDA Clinical Trials Statutory and 
Regulatory Requirements'' workshop helps fulfill the Department of 
Health and Human Services' and FDA's important mission to protect the 
public health by educating researchers on proper conduct of clinical 
trials. FDA has made education of the research community a high 
priority to assure the quality of clinical data and protect research 
subjects.
    The workshop helps to implement the objectives of section 406 of 
the FDA Modernization Act (21 U.S.C. 393) and the FDA Plan for 
Statutory Compliance, which includes working more closely with 
stakeholders and ensuring access to needed scientific and technical 
expertise. The workshop also furthers the goals of the Small Business 
Regulatory Enforcement Fairness Act (Public Law 104-121) by providing 
outreach activities by Government agencies directed to small 
businesses.

    Dated: March 5, 2004.
Jeffrey Shuren,
Assistant Commissioner for Policy.
[FR Doc. 04-5489 Filed 3-10-04; 8:45 am]
BILLING CODE 4160-01-S