Document ID: FDA-2009-N-0664-0128
Agency: fda
Document Type: Notice
Title: Food and Drug Administration Clinical Trial Requirements, Regulations, Compliance and Good Clinical Practices; Public Workshop
Posted Date: 2009-12-17T05:00Z

[Federal Register: December 17, 2009 (Volume 74, Number 241)]
[Notices]               
[Page 66988-66989]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr17de09-61]                         

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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, 
Regulations, Compliance and Good Clinical Practices; Public Workshop

AGENCY:  Food and Drug Administration, HHS.

ACTION:  Notice of public workshop.

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SUMMARY:  The Food and Drug Administration (FDA) Florida District, in 
cosponsorship with The Society of Clinical Research Associates, Inc. 
(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 Wednesday, March 
3, 2010, from 8 a.m. to 5 p.m., and Thursday, March 4, 2010, from 8 
a.m. to 4:35 p.m.
    Location: The public workshop will be held at The Wyndham Orlando 
Resort, 8001 International Dr., Orlando, FL 32819, 407-351-2420.
    Attendees are responsible for their own accommodations. To make 
reservations at the Wyndham Orlando Resort, at the discounted rate of 
$149 per night (plus applicable taxes), contact the hotel before 
February 10, 2010, citing ``SoCRA''. The hotel's Web site is: http://
www.wyndham.com/hotels/MCOWD/main.wnt. (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.)
    Contacts:
    For FDA: C. Stewart Watson, Food and Drug Administration, 555 
Winderley Pl., suite 200, Maitland, FL 32751, 407-475-4756, FAX: 407-
475-4768, e-mail: charles.watson@fda.hhs.gov.
    For SoCRA: SoCRA Administrative Office, 530 West Butler Ave., suite 
109, Chalfont, PA 18914, 1-800-762-7292 or 215-822-8644, FAX: 215-822-
8633, e-mail: SoCRAmail@aol.com.
    Registration: You are encouraged to register by February 26, 2010. 
Seats are limited; please submit your registration as soon as possible. 
Workshop space will be filled in order of receipt of registration. 
Registration will close when the workshop is filled. Those accepted 
into the workshop will receive confirmation. 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 SoCRA registration 
fees cover the cost of the workshop facilities, materials, breaks, and 
lunches. 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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Federal Government (SoCRA Member)                                                                        $450.00
----------------------------------------------------------------------------------------------------------------
Federal Government (Non-SoCRA Member)                                                                    $525.00
----------------------------------------------------------------------------------------------------------------
Non-Federal Government (SoCRA Member)                                                                    $575.00
----------------------------------------------------------------------------------------------------------------
Non-Federal Government (Non-SoCRA Member)                                                                $650.00
----------------------------------------------------------------------------------------------------------------

    If you need special accommodations due to a disability, please 
contact C. Stewart Watson at least 7 days in advance of the meeting.
    Registration instructions: To register, please submit your name, 
affiliation,

[[Page 66989]]

mailing address, phone/fax number, and e-mail, along with a check or 
money order payable to SoCRA. Please mail your payment to: SoCRA 
Administrative Office, 530 West Butler Ave., suite 109, Chalfont, PA 
18914. Registration may be downloaded on the SoCRA Web site at http://
www.socra.org. (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.)
    Other payment forms accepted are major credit cards (VISA, 
MasterCard, or American Express only). For more information on the 
meeting, or for questions on registration, contact the SoCRA 
Administrative Office (see Contact).

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 public 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 investigations, electronic record requirements, and investigator 
initiated research. Topics for discussion include the following: (1) 
What FDA Expects in a Pharmaceutical Clinical Trial, (2) Adverse Event 
Reporting, (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 the FDA, (9) Investigator 
Initiated Research, (10) Medical Device Aspects of Clinical Research, 
(11) Working with FDA's Center for Biologics Evaluation and Research, 
(12) Ethical Issues in Subject Enrollment, (13) 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: December 10, 2009.
David Horowitz,
Assistant Commissioner for Policy.
[FR Doc. E9-30017 Filed 12-16-09; 8:45 am]

BILLING CODE 4160-01-S