[Federal Register Volume 74, Number 164 (Wednesday, August 26, 2009)]
[Notices]
[Pages 43141-43142]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: E9-20340]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

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


Industry Exchange Workshop on Food and Drug Administration Drug 
and Device 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 cosponsorship with the Society of Clinical Research Associates 
(SoCRA) is announcing a public workshop entitled: ``FDA Clinical Trial 
Requirements, Regulations, Compliance and GCP.'' 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 October 21, 
2009, from 8:30 a.m. to 5 p.m. and October 22, 2009, from 8:30 a.m. to 
5 p.m.
    Location: The public workshop will be held at the Hyatt Regency 
Pittsburgh International Airport, 1111 Airport Blvd., Pittsburgh, PA 
15231, 724-899-1234 or 1-800-233-1234.
    Attendees are responsible for their own accommodations. To make 
reservations at the Hyatt Regency Hotel, contact the Hyatt Regency 
Hotel.
    Contact: Marie Falcone, Food and Drug Administration, U.S. 
Customhouse, 200 Chestnut St., rm. 900, Philadelphia, PA 19106, 215-
717-3703, FAX: 215-597-4660, e-mail: <a href="/cdn-cgi/l/email-protection#a6cbc7d4cfc388c0c7cac5c9c8c3e6c0c2c788ceced588c1c9d0"><span class="__cf_email__" data-cfemail="3954584b505c175f58555a56575c795f5d581751514a175e564f">[email protected]</span></a>.
    Registration: You are encouraged to register by October 19, 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 in to 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:

                          Cost of Registration
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                 Affiliation                              Fee
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FDA Employee                                  Fee Waived
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Government (Non-Member)                       $525.00
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[[Page 43142]]

 
Non-Government (SoCRA Member)                 $575.00
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Non-Government (Non SoCRA Member)             $650.00
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    If you need special accommodations due to a disability, please 
contact Marie Falcone (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, 
telephone, fax number, and e-mail address, 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 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 (VISA/MasterCard/AMEX 
only). For more information on the public workshop, or for questions on 
registration, contact the Society of Clinical Research Associates at 
800-762-7292 or 215-822-8644, FAX: 215-822-8633, or e-mail: 
<a href="/cdn-cgi/l/email-protection#7f2c103c2d3e121e16133f1e1013511c1012"><span class="__cf_email__" data-cfemail="c291ad819083afa3abae82a3adaeeca1adaf">[email protected]</span></a>.

SUPPLEMENTARY INFORMATION: The public workshop helps fulfill the 
Department of Health and Human Services' and FDA's important mission to 
protect the public health. The workshop will provide those engaged in 
FDA-regulated (human) clinical trials with information on a number of 
topics concerning FDA requirements related to informed consent, 
clinical investigation requirements, institutional review board (IRB) 
inspections, electronic record requirements, and investigator initiated 
research. Topics for discussion include the following:
    <bullet> What FDA Expects in a Pharmaceutical Clinical Trial;
    <bullet> Adverse Event Reporting--Science, Regulation, Error, and 
Safety;
    <bullet> Part 11 Compliance--Electronic Signatures;
    <bullet> Informed Consent Regulations;
    <bullet> IRB Regulations and FDA Inspections;
    <bullet> Keeping Informed and Working Together;
    <bullet> FDA Conduct of Clinical Investigator Inspections;
    <bullet> Meetings With FDA: Why, When, and How;
    <bullet> Investigator Initiated Research;
    <bullet> Medical Device Aspects of Clinical Research;
    <bullet> Working With FDA's Center for Biologics Evaluation and 
Research; and
    <bullet> 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 public 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 public workshop also is consistent with the Small Business 
Regulatory Enforcement Fairness Act of 1996 (Public Law 104-121), as 
outreach activities by Government agencies to small businesses.

    Dated: August 18, 2009.
David Horowitz,
Assistant Commissioner for Policy.
[FR Doc. E9-20340 Filed 8-25-09; 8:45 am]
BILLING CODE 4160-01-S


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