[Federal Register Volume 70, Number 31 (Wednesday, February 16, 2005)]
[Notices]
[Page 7950]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 05-2922]


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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: [email protected].
    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://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: 
[email protected]. 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