[Federal Register: September 21, 2005 (Volume 70, Number 182)]
[Notices]
[Page 55405]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr21se05-92]
-----------------------------------------------------------------------
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.
-----------------------------------------------------------------------
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: oraswrsbr@ora.fda.gov.
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://frwebgate.access.gpo.gov/cgi-bin/leaving.cgi?from=leavingFR.html&log=linklog&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: socramail@aol.com. 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