[Federal Register Volume 75, Number 162 (Monday, August 23, 2010)]
[Pages 51824-51825]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2010-20834]



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.


[[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 
    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]