Document ID: FDA-2013-N-0001-0083
Agency: fda
Document Type: Notice
Title: Society of Clinical Research Associates-Food and Drug Administration:  Food and Drug Administration Clinical Trial Requirements, Regulations, Compliance, and Good Clinical Practice; Public Workshop
Posted Date: 2013-09-11T04:00Z

[Federal Register Volume 78, Number 176 (Wednesday, September 11, 2013)]
[Notices]
[Pages 55728-55729]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2013-22115]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2013-N-0001]

Society of Clinical Research Associates-Food and Drug 
Administration: Food and Drug Administration Clinical Trial 
Requirements, Regulations, Compliance, and Good Clinical Practice; 
Public Workshop

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice of public workshop.

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    The Food and Drug Administration (FDA) is announcing the following 
public workshop entitled ``Educational Conference Co-Sponsored With the 
Society of Clinical Research Associates (SoCRA).'' The public workshop 
regarding FDA's clinical trial requirements is designed to aid the 
clinical research professional's understanding of the mission, 
responsibilities, and authority of FDA, and to facilitate interaction 
with FDA representatives. The program will focus on the relationships 
among FDA and clinical trial staff, investigators, and institutional 
review boards (IRBs). Individual FDA representatives will discuss the 
informed consent process including the informed consent documents; 
regulations relating to drugs, devices, and biologics; as well as 
inspections of clinical investigators, of IRBs, and of research 
sponsors.
    Date and Time: The public workshop will be held on November 6 and 
7, 2013, from 8 a.m. to 5 p.m.
    Location: The public workshop will be held at the JW Marriott 
Atlanta Buckhead Hotel, 3300 Lenox Rd. NE., Atlanta, GA 30326, 404-262-
3344.
    Attendees are responsible for their own accommodations. Please 
mention SoCRA to receive the hotel room rate of $185.00 plus applicable 
taxes (available until October 15, 2013, or until the SoCRA room block 
is filled).
    Contact Person: JoAnn Pittman, Food and Drug Administration, 60 
Eighth Street NE., Atlanta, GA 30309, voicemail: 404-253-1272, FAX: 
404-253-1202, or Society of Clinical Research Associates (SoCRA), 530 
West Butler Ave., Suite 109, Chalfont, PA 18914, 800-762-7292 or 215-
822-8644, FAX: 215-822-8633, email: SoCRAmail@aol.com, Web site: 
www.socra.org.
    Registration: The registration fee will cover actual expenses 
including refreshments, lunch, materials, and speaker expenses. Seats 
are limited; please submit your registration as soon as possible. 
Workshop space will be filled in order of receipt of registration. 
Those accepted into the workshop will receive confirmation. The cost of 
the registration is as follows:

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SoCRA member..............................  $575.00.
SoCRA nonmember (includes membership).....  $650.00.
Federal Government SoCRA member...........  $450.00.
Federal Government SoCRA nonmember........  $525.00.
FDA Employee..............................  (Free) Fee Waived.
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    If you need special accommodations due to a disability, please 
contact SoCRA, 800-762-7292 or 215-822-8644, FAX: 215-822-8633, or 
email: SoCRAmail@aol.com at least 21 days in advance.
    Extended periods of question and answer and discussion have been 
included in the program schedule. SoCRA designates this education 
activity for a maximum of 13.3 Continuing Education (CE) credits for 
SoCRA CE and continuing nurse education (CNE). SoCRA designates this 
live activity for a maximum of 13.3 American Medical Association 
Physicians Recognition Award Category 1 Credit(s)TM. 
Physicians should claim only the credit commensurate with the extent of 
their participation. Continuing Medical Education for physicians: SoCRA 
is accredited by the Accreditation Council for Continuing Medical 
Education to provide continuing medical education for physicians. CNE 
for nurses: SoCRA is an approved provider of CNE by the Pennsylvania 
State Nurses Association (PSNA), an accredited approver by the American 
Nurses Credentialing Center's Commission on Accreditation (ANCC). ANCC/
PSNA Provider Reference Number: 205-3-A-09.
    Registration instructions: To register, please submit a 
registration form with your name, affiliation, mailing address, 
telephone, fax number, and email, along with a check or money order 
payable to ``SoCRA''. Mail to: Society of Clinical Research Associates 
(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 addresses 
throughout this document, but we are not responsible for any subsequent 
changes to the Web sites after this document is published in the 
Federal Register).
    Payment by major credit card is accepted (Visa/MasterCard/AMEX 
only). For more information on the meeting registration, or for 
questions on the public workshop, contact SoCRA, 800-762-7292 or 215-
822-8644, FAX: 215-822-8633, or email: 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. 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, IRB inspections, 
electronic record requirements, and investigator initiated research. 
Topics for discussion include the following: (1) The Role of the FDA 
District Office Relative to the Bioresearch Monitoring Program (BIMO); 
(2) Modernizing FDA's Clinical Trials/BIMO Programs; (3) What FDA 
Expects in a Pharmaceutical Clinical Trial; (4) Medical Device Aspects 
of Clinical Research; (5) Adverse Event Reporting--Science, Regulation, 
Error, and Safety; (6) Working with FDA's Center for Biologics 
Evaluation and Research; (7) Ethical Issues in Subject Enrollment; (8) 
Keeping Informed and Working

[[Page 55729]]

Together; (9) FDA Conduct of Clinical Investigator Inspections; (10) 
Investigator Initiated Research; (11) Meetings with FDA--Why, When, and 
How; (12) Part 11 Compliance--Electronic Signatures; (13) IRB 
Regulations and FDA Inspections; (14) Informed Consent Regulations; 
(15) The Inspection is Over--What Happens Next? Possible FDA Compliance 
Actions; and (16) Question and Answer Session/Panel Discussion.
    FDA has made education of the drug and device manufacturing 
community a high priority to help ensure the safety and effectiveness 
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: September 6, 2013.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2013-22115 Filed 9-10-13; 8:45 am]
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