[Federal Register Volume 68, Number 102 (Wednesday, May 28, 2003)]
[Notices]
[Pages 31720-31721]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 03-13192]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration


FDA/Industry Exchange Workshop on FDA Clinical Trials Statutory 
and Regulatory 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. Topics for discussion include: Financial 
incentives and funding, pre-IND (investigational new drug application) 
meetings and FDA meeting process, medical device aspects of clinical 
research, informed consent requirements, adverse event reporting, how 
FDA conducts bioresearch inspections, ethics in clinical research, FDA 
and confidence in the conduct of clinical research, and how FDA 
addresses fraud in clinical research. 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, June 
25, 2003, from 8:30 a.m. to 4:45 p.m. and Thursday, June 26, 2003, from 
8:45 a.m. to 4:45 p.m.
    Location: The public workshop will be held at the Pittsburgh 
Marriott Center City Hotel, 112 Washington Pl., Pittsburgh, PA 15219.
    Contact: Daniel R. Tammariello, FDA, 7 Parkway Center, Suite 250, 
Pittsburgh, PA 15220, 412-644-3394, ext. 16, FAX: 412-644-4496, e-mail: 
[email protected] or Marie Falcone, Industry and Small Business 
Representative, FDA, Room 900 U.S. Customhouse, 200 Chestnut St.,

[[Page 31721]]

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 $460 (member) or 
$535 (non-member) registration fee made 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.
    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 to 
[email protected]. Attendees are responsible for their own 
accommodations. To make reservations at the Pittsburgh Marriott Center 
City Hotel at the reduced conference rate, contact the Pittsburgh 
Marriott Center City Hotel at 412-471-4000 or 888-456-6600 or by fax at 
hotel FAX: 412-281-4797 before June 3, 2003.
    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 at least 7 days in advance of the workshop.

SUPPLEMENTARY INFORMATION: The ``FDA Clinical Trials Statutory and 
Regulatory Requirements'' workshop 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. 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: May 20, 2003.
Jeffrey Shuren,
Assistant Commissioner for Policy.
[FR Doc. 03-13192 Filed 5-27-03; 8:45 am]
BILLING CODE 4160-01-S