[Federal Register: February 16, 2005 (Volume 70, Number 31)]
[Notices]
[Page 7950]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr16fe05-56]
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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) Philadelphia 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,
April 13, 2005, from 8:15 a.m. to 5 p.m. and Thursday, April 14, 2005,
from 8:15 a.m. to 4 p.m.
Location: The public workshop will be held at the Sheraton
University City Hotel Philadelphia, 3549 Chestnut St., Philadelphia, PA
19104, 215-387-8000, FAX: 215-387-7920.
Contact: Marie Falcone, Food and Drug Administration, U.S.
Customhouse, 200 Chestnut St., rm. 900, Philadelphia, PA 19106, 215-
597-2120 ext. 4003, FAX: 215-597-5798, e-mail: mfalcone@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 nonmemebers 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/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 Sheraton University City
Hotel at the reduced conference rate, contact the Sheraton University
City Hotel (see Location) before March 13, 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 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 and
confidence in 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 (IND)
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 assure 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: February 4, 2005.
Jeffrey Shuren,
Assistant Commissioner for Policy.
[FR Doc. 05-2922 Filed 2-15-05; 8:45 am]
BILLING CODE 4160-01-S