[Federal Register: September 8, 2008 (Volume 73, Number 174)]
[Notices]
[Page 52052]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr08se08-71]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2008-N-0038]
FDA Clinical Trial Requirements Regulations, Compliance, and Good
Clinical Practice Conference; Public Workshop
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice of public workshop.
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SUMMARY: The Food and Drug Administration (FDA) Dallas District, in
cooperation with the Society of Clinical Research Associates(SoCRA), is
announcing a workshop on FDA Clinical Trial statutory and regulatory
requirements. This 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,
November 19, 2008, from 8 a.m. to 5 p.m. and Thursday, November 20,
2008, from 8 a.m. to 5 p.m.
Location: The public workshop will be held at the Westin Crown
Center, 1 East Pershing Rd., Kansas City, MO 64118, 816-474-4400, FAX:
816-391-4438.
Contact: David Arvelo, Food and Drug Administration, 4040 N.
Central Expressway, suite 900, Dallas, TX 75204, 214-253-4952, FAX:
214-253-4970, e-mail: david.arvelo@fda.hhs.gov.
Registration: Send registration information (including name, title,
firm name, address, telephone, and fax number) and the registration fee
of $575 (member), $650 (nonmember), $525 (government employee
nonmember), or $450 (government employee member). (Registration fee for
nonmembers includes a 1-year membership.) The registration fee for FDA
employees is waived. Make the registration fee payable to SoCRA, 530
West Butler Ave., suite 109, Chalfont, PA 18914. To register via the
Internet go to http://www.socra.org/html/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.) The 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 215-822-8644, or
via e-mail: socramail@aol.com. Attendees are responsible for their own
accommodations. To make reservations at the Westin Crown Center at the
reduced conference rate, contact the Westin Crown Center (see Location)
before October 21, 2008. 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
David Arvelo (see Contact) at least 21 days in advance of the workshop.
SUPPLEMENTARY INFORMATION: The FDA Clinical Trial Requirements
Regulations, Compliance, and GCP Conference, 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. Topics for discussion include the following: (1) FDA
and confidence in the conduct of clinical research; (2) medical device,
drug, biological product, and food additive aspects of clinical
research; (3) investigator initiated research; (4) Pre-investigational
new drug (IND) application meetings and FDA meeting process; (5)
informed consent requirements; (6) ethics in subject enrollment; (7)
FDA regulation of Institutional Review Boards; (8) electronic records
requirements; (9) adverse event reporting; (10) how FDA conducts
bioresearch inspections, and (11) what happens after the FDA
inspection. 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: September 2, 2008.
Jeffrey Shuren,
Associate Commissioner for Policy and Planning.
[FR Doc. E8-20730 Filed 9-5-08; 8:45 am]
BILLING CODE 4160-01-S