[Federal Register: March 28, 2007 (Volume 72, Number 59)]
[Notices]
[Page 14583-14584]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr28mr07-77]
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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) Chicago 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 May 16, 2007,
from 8:30 a.m. to 5 p.m. and May 17, 2007, from 8:30 a.m. to 4:30 p.m.
Location: The public workshop will be held at the Oak Brook Hills
Marriott Resort, 3500 Midwest Rd., Oak Brook, IL 60523, 630-850-5555,
FAX: 630-850-5569.
Contact: Marie Falcone, Food and Drug Administration, U.S.
Customhouse, 200 Chestnut St., rm. 900, Philadelphia, PA 19106, 215-
717-3703, FAX: 215-597-5798, e-mail: marie.falcone@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 (Federal 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 to http://www.socra.org
(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 Oak Brook Hills Marriott
Resort, at the reduced conference rate, contact the Oak Brook Hills
Marriott Resort (see Location) before April 24, 2007, citing meeting
code SCRSCRA. 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 Marie Falcone (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 and food 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
[[Page 14584]]
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: March 22, 2007.
Jeffrey Shuren,
Assistant Commissioner for Policy.
[FR Doc. E7-5633 Filed 3-27-07; 8:45 am]
BILLING CODE 4160-01-S