[Federal Register: December 13, 2006 (Volume 71, Number 239)]
[Notices]
[Page 74927-74928]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr13de06-57]
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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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The Food and Drug Administration (FDA) Los Angeles 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 7, 2007, from 8:30 a.m. to 5 p.m. and Thursday, February 8,
2007, from 8:30 a.m. to 4:30 p.m.
Location: The public workshop will be held at the Wyndham San Diego
at Emerald Plaza, 400 West Broadway, San Diego, CA 92101, 619-239-4500,
FAX: 619-239-3274.
Contact: Marshalette Edwards, Food and Drug Administration, 1431
Harbor Bay Parkwy., Alameda, CA 94502, 510-337-6794, FAX: 510-337-6703
e-mail: MO.Edwards@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) to SoCRA , P.O. Box
101, Furlong, PA 18925. The registration fee for nonmembers includes a
1-year membership). The registration fee for FDA employees is waived.
Make the registration fee payable to SoCRA.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 215-822-8644, or via e-mail:
socramail@aol.com. Attendees are responsible for their own
accommodations. To make reservations at the Wyndham San Diego at
Emerald Plaza at the reduced conference rate, contact the hotel (see
Location) before January 7, 2007. 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 Marshalette Edwards
(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 the 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
[[Page 74928]]
bioresearch inspections; and (11) what happens after the FDA
inspection.
FDA has made the 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: December 6, 2006.
Jeffrey Shuren,
Assistant Commissioner for Policy.
[FR Doc. E6-21138 Filed 12-12-06; 8:45 am]
BILLING CODE 4160-01-S