[Federal Register: March 11, 2004 (Volume 69, Number 48)]
[Notices]
[Page 11636-11637]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr11mr04-109]
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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 nbellamy@ora.fda.gov 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: mfalcone@ora.fda.gov.
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://frwebgate.access.gpo.gov/cgi-bin/leaving.cgi?from=leavingFR.html&log=linklog&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
socramail@aol.com. 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