[Federal Register Volume 75, Number 162 (Monday, August 23, 2010)]
[Notices]
[Pages 51824-51825]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2010-20834]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2010-N-0001]
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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[[Page 51825]]
SUMMARY: The Food and Drug Administration (FDA) New Jersey District
Office, in cosponsorship with the Society of Clinical Research
Associates (SoCRA) is announcing a public workshop. The public workshop
on 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 and informed consent documents; regulations relating to
drugs, devices, and biologics; as well as inspections of clinical
investigators, IRBs, and research sponsors.
Date and Time: The public workshop will be held on November 4 and
5, 2010, from 8 a.m. to 5 p.m.
Location: The public workshop will be held at the Hyatt Regency
Jersey City, Two Exchange Pl., Jersey City, NJ 07302, 1-800-233-1234.
(The hotel is connected to the PATH Train to New York City). Attendees
are responsible for their own accommodations. Please mention SoCRA to
receive the hotel room rate of $169 plus applicable taxes (available
until October 20, 2010, or until the SoCRA room block is filled).
Contact: Joan Lytle, Food and Drug Administration, 120 North
Central Dr., North Brunswick, NJ 08902, 732-940-8946 ext. 33, FAX: 732-
940-8936, or Society of Clinical Research Associates (SoCRA), 530 West
Butler Ave., suite 109, Chalfont, PA 18914, 800-762-7292, FAX: 215-822-
8633, email: [email protected], Web site: http://www.SoCRA.org.
Registration: The registration fee covers the cost of 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 or receipt of
registration. Those accepted into the workshop will receive
confirmation. The cost of registration is as follows: SoCRA member
($575.00), SoCRA nonmember (includes membership) ($650.00), FDA/Federal
Government member ($450.00), FDA/Federal Government nonmember
($525.00).
If you need special accommodations due to a disability, please
contact SoCRA (see Contact) at least 10 days in advance.
Extended periods of question and answer and discussion have been
included in the program schedule. This program offers 13.3 hours of
continuing medical education (CME) and continuing nursing education
(CNE) credit. CME 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, phone,
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 address, but we are not responsible for any
subsequent changes to the Web site after this document publishes 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 Contacts).
SUPPLEMENTARY INFORMATION: The public conference 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, IRB inspections, 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--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 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 17, 2010.
Leslie Kux,
Acting Assistant Commissioner for Policy.
[FR Doc. 2010-20834 Filed 8-20-10; 8:45 am]
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