[Federal Register Volume 75, Number 57 (Thursday, March 25, 2010)]
[Pages 14448-14449]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2010-6579]



Food and Drug Administration

[Docket No. FDA-2010-N-0001]

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.


SUMMARY: The Food and Drug Administration (FDA) Los Angeles District 
Office, in cosponsorship with the Society of Clinical Research 
Associates, Inc. (SoCRA) is announcing a public workshop entitled ``FDA 
Clinical Trial Requirements, Regulations, Compliance, and Good Clinical 
Practices.'' The public workshop is intended 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 the 
FDA and clinical trial staff, investigators, and ivestigational review 
boards (IRBs). Individual FDA representatives will discuss the informed 
consent process and informed consent documents, and 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 Wednesday and 
Thursday, May 5 and 6, 2010, from 8 a.m. to 5 p.m.
    Location: The public workshop will be held at the Hyatt Regency 
Newport Beach, 1107 Jamboree Rd., Newport Beach, CA 92660, 949-729-
    Contact: Linda Hartley, Food and Drug Administration, 19701 
Fairchild, Irvine, CA 92612, 949-608-4413, FAX: 949-608-4417. Attendees 
are responsible for their own accommodations. To make reservations at 
the Hyatt Regency Newport Beach, contact the Hyatt Regency Newport 
Beach (see Location).
    Registration: The SoCRA registration fees cover 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 of receipt of 
registration. Those accepted into the workshop will receive 
confirmation. Registration will close after the workshop is filled. 
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 cost of registration is as follows: FDA employee (fee waived), 
Government employee member ($450), Government employee nonmember 
($525), non-Government employee SoCRA member ($575), non-Government 
employee non-SoCRA member ($650).
    If you need special accommodations due to a disability, please 
contact Linda Hartley (see Contact) at least 10 days in advance of the 
public workshop.
    Extended periods of question and answer and discussion have been 
included in the program schedule.
    Registration instructions: To register, please submit a 
registration form with your name, affiliation, mailing address, phone, 
fax number, and e-mail, along with a check or money order payable to 
``SoCRA.'' Mail to: 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 address, but 
we are not responsible for any subsequent changes to the Web site after 
this document publishes in the Federal Register.)
    The registrar will also accept payment by major credit cards (VISA/
MasterCard/AMEX only). For more information on the meeting, or for 
questions on registration, contact SoCRA at 800-762-7292 or 215-822-
8644, FAX: 215-822-8633, or e-mail: [email protected].

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 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 
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)

[[Page 14449]]

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; and (12) The inspection is over--what happens 
next? What are the 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 workshop also is consistent with the Small Business 
Regulatory Enforcement Fairness Act of 1996 (Public Law 104-121) as an 
outreach activity by Government agencies to small businesses.

    Dated: March 19, 2010.
Leslie Kux,
Acting Assistant Commissioner for Policy.
[FR Doc. 2010-6579 Filed 3-24-10; 8:45 am]