[Federal Register: August 11, 2006 (Volume 71, Number 155)]
[Notices]
[Page 46231-46232]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr11au06-76]
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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) Detroit 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 15, 2006, from 8:30 a.m. to 5 p.m. and Thursday, November 16,
2006, from 8:30 a.m. to 4:30 p.m.
Location: The public workshop will be held at the Sheraton
Indianapolis Hotel & Suites, 8787 Keystone Crossing, Indianapolis, IN
46240, 317-846-2700, FAX: 317-574-6775.
Contact: Nancy Bellamy, Food and Drug Administration, 300 River
Pl., suite 5900, Detroit, MI, 48207, 313-393-8143, FAX: 313-393-8139,
e-mail: nancy.bellamy@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), or $525 (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, 530 West Butler Ave., suite 109,
Chalfont, PA, 18914. To register via the Internet go tohttp://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 215-822-8644, or via e-mail:
socramail@aol.com. Attendees are responsible for their own
accommodations. To make reservations at the Sheraton Indianapolis Hotel
& Suites, at the reduced conference rate, contact the Sheraton
Indianapolis Hotel & Suites (see Location) before October 22, 2006. 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 Nancy Bellamy (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,
biological product and food 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.
[[Page 46232]]
Dated: August 4, 2006.
Jeffrey Shuren,
Assistant Commissioner for Policy.
[FR Doc. E6-13114 Filed 8-10-06; 8:45 am]
BILLING CODE 4160-01-S