[Federal Register Volume 79, Number 198 (Tuesday, October 14, 2014)]
[Notices]
[Pages 61645-61646]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2014-24307]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2014-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 an 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 (IRB). Individual FDA
representatives will discuss the informed consent process and informed
consent documents; regulations relating to drugs, devices, and
biologics; as well as inspections of clinical investigators, IRB, and
research sponsors.
Date and Time: The public workshop will be held on November 5 and
6, 2014, from 8 a.m. to 5 p.m.
Location: The public workshop will be held at the Wyndham Lake
Buena Vista Hotel, 1850 Hotel Plaza Blvd., Lake Buena Vista, FL 32830,
407-828-4444.
Attendees are responsible for their own accommodations. Please
mention SoCRA to receive the hotel room rate of $95.00 plus applicable
taxes (available until October 6, 2014, or until the SoCRA room block
is filled).
Contact: C. Stewart Watson, Food and Drug Administration, 555
Winderley Pl., Suite 200, Maitland, FL 32751, 407-475-4756, FAX: 407-
475-4768, 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 [email protected], 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: SoCRA member--$575; SoCRA nonmember
(includes membership)--$650; Federal Government member--$450.00;
Federal Government SoCRA nonmember--$525.00; FDA Employee--Fee Waived.
If you need special accommodations due to a disability, please
contact SoCRA (see Contact) 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 nursing 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 continuing nursing
education 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: SoCRA (see Contact for address). 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
[[Page 61646]]
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 workshop, contact SoCRA (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 informed consent,
clinical investigation requirements, institutional review board
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 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; (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 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 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: October 7, 2014.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2014-24307 Filed 10-10-14; 8:45 am]
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