[Federal Register Volume 73, Number 174 (Monday, September 8, 2008)]
[Notices]
[Page 52052]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: E8-20730]


-----------------------------------------------------------------------

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.

-----------------------------------------------------------------------

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: [email protected].
    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: [email protected]. 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