Document ID: FDA-2009-N-0664-0046
Agency: fda
Document Type: Notice
Title: Food and Drug Administration Clinical Trial Requirements; Public Workshop
Posted Date: 2009-05-22T04:00Z

[Federal Register: May 22, 2009 (Volume 74, Number 98)]
[Notices]               
[Page 24022]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr22my09-71]                         

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2009-N-0664]

 
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) Minneapolis District, 
in cosponsorship with the Society of Clinical Research Associates, Inc. 
(SoCRA) is announcing a public workshop entitled ``FDA Clinical Trial 
Requirements.'' This 2-day public workshop is intended to provide 
information about FDA clinical trial requirements to the regulated 
industry.
    Date and Time: The public workshop will be held on Wednesday, June 
10, 2009, from 8:30 a.m. to 5 p.m., and Thursday, June 11, 2009, from 
8:30 a.m. to 5 p.m.
    Location: The public workshop will be held at the Radisson 
University Hotel, Suite 600, 615 Washington Ave., SE., Minneapolis, MN 
55414, 612-379-8888 or 1-800-822-6757 or 888-201-1718.
    Contact: Carrie Hoffman, Food and Drug Administration, 250 
Marquette Ave., Minneapolis, MN 55401, 612-758-7200, FAX: 612-334-4142, 
e-mail: carrie.hoffman@fda.hhs.gov.
    Attendees are responsible for their own accommodations. To make 
reservations at the Radisson University Hotel, contact the Radisson 
University Hotel (see Location).
    Registration: You are encouraged to register by June 9, 2009. The 
SoCRA registration fees cover the cost of facilities, materials, and 
breaks. Seats are limited; please submit your registration as soon as 
possible. Course space will be filled in order of receipt of 
registration. Those accepted into the course will receive confirmation. 
Registration will close after the course is filled. Registration at the 
site is not guaranteed but may be possible on a space available basis 
on the day of the public workshop beginning at 8 a.m. The cost of 
registration is as follows: FDA employee (fee waived), Government 
employee nonmember ($525), non-Government employee SoCRA member ($575), 
non-Government employee non-SoCRA member ($650).
    If you need special accommodations due to a disability, please 
contact Carrie Hoffman (see Contact) at least 7 days in advance of the 
workshop.
    Registration Instructions: To register, please submit a 
registration form with your name, affiliation, mailing address, phone, 
fax number, and e-mail, along with a check or money order payable to 
``SoCRA.'' Mail to: SoCRA, 530 West Butler Ave., Suite 109, Chalfont, 
PA 18914. To register via the Internet, go to http://www.socra.org/
html/FDA_Conference.htm. (FDA has verified the Web site address, but 
we are not responsible for any subsequent changes to the Web site after 
this document publishes in the Federal Register.)
    The registrar will also accept payment by major credit cards (VISA/
MasterCard/AMEX only). For more information on the meeting, or for 
questions on registration, contact SoCRA at 800-762-7292 or 215-822-
8644, FAX: 215-822-8633, or e-mail: SoCRAmail@aol.com.

SUPPLEMENTARY INFORMATION: The public workshop helps fulfill the 
Department of Health and Human Services' and FDA's important mission to 
protect the public health. Topics for discussion include the following: 
(1) What FDA Expects in a Pharmaceutical Clinical Trial; (2) Adverse 
Event Reporting--Science, Regulation, Error and Safety; (3) Part 11 
Compliance--Electronic Signatures; (4) Informed Consent Regulations; 
(5) IRB Regulations and FDA Inspections; (6) Keeping Informed and 
Working Together; (7) FDA Conduct of Clinical Investigator Inspections; 
(8) Meetings with FDA: Why, When, and How; (9) Investigator Initiated 
Research; (10) Medical Device Aspects of Clinical Research; (11) 
Working with FDA's Center for Biologics Evaluation and Research; (12) 
The Inspection is Over--What Happens Next? Possible FDA Compliance 
Actions.
    FDA has made education of the drug and device manufacturing 
community a high priority to help ensure the quality of FDA-regulated 
drugs and devices. The workshop helps to achieve objectives set forth 
in section 406 of the FDA Modernization Act of 1997 (21 U.S.C. 393) 
which includes working closely with stakeholders and maximizing the 
availability and clarity of information to stakeholders and the public. 
The workshop also is consistent with the Small Business Regulatory 
Enforcement Fairness Act of 1996 (Pub. L. 104-121), as outreach 
activities by Government agencies to small businesses.

    Dated: May 18, 2009.
Jeffrey Shuren,
Associate Commissioner for Policy and Planning.
[FR Doc. E9-12051 Filed 5-21-09; 8:45 am]

BILLING CODE 4160-01-S