[Federal Register Volume 70, Number 182 (Wednesday, September 21, 2005)]
[Notices]
[Page 55405]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 05-18871]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration


Industry Exchange Workshop on Food and Drug Administration 
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) 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, 
February 8, 2006, from 8:15 a.m. to 5 p.m. and Thursday, February 9, 
2006, from 8:15 a.m. to 4 p.m.
    Location: The public workshop will be held at the Crowne Plaza 
Hotel Houston Medical Center, 6701 South Main, Houston, TX 77030, 713-
797-1110, FAX: 713-796-8291.
    Contact: David Arvelo, Food and Drug Administration, 4040 North 
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 $485 (member), $560 (nonmember), or $460 (government employee 
nonmember). (Registration fee for nonmembers includes a 1-year 
membership.) The registration fee for FDA employees is waived. Make the 
registration fee payable to SoCRA, P.O. Box 101, Furlong, PA 18925. 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 
215-345-7369, or via e-mail: [email protected]. Attendees are 
responsible for their own accommodations. To make reservations at the 
Crowne Plaza Hotel Houston Medical Center at the reduced conference 
rate, contact the Crowne Plaza Hotel Houston Medical Center (see 
Location) before January 17, 2005. 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 7 days in advance of the workshop.

SUPPLEMENTARY INFORMATION: The workshop on FDA clinical trials 
statutory and regulatory requirements, 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 regulation 
of the conduct of clinical research; (2) medical device, drug, and 
biological product aspects of clinical research; (3) investigator 
initiated research; (4) pre-investigational new drug 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 ensure 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 15, 2005.
Jeffrey Shuren,
Assistant Commissioner for Policy.
[FR Doc. 05-18871 Filed 9-20-05; 8:45 am]
BILLING CODE 4160-01-S