[Federal Register Volume 78, Number 66 (Friday, April 5, 2013)]
[Pages 20664-20665]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2013-07894]



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

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice of conference.


SUMMARY: The Food and Drug Administration (FDA) is announcing an 
educational conference co-sponsored with the Society of Clinical 
Research Associates (SOCRA). The conference 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, and regulations relating to drugs, devices, and 
biologics, as well as inspections of clinical investigators, IRBs, and 
research sponsors.

DATES: Date and Time: The conference will be held on May 15 and 16, 
2013, from 8 a.m. to 5 p.m.
    Location: The conference will be held at the Renaissance Seattle 
Hotel, 515 Madison St., Seattle, WA 98104.
    Contact Person: Jane Kreis, Food and Drug Administration, 1301 Clay 
St., Suite 1180N, Oakland, CA 94612, 510-287-2708, FAX: 510-287-2739; 
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: www.socra.org.
    Registration and Meeting Information: See SOCRA Web site, 
www.SoCRA.org. http://www.socra.org/html/FDA_Conference.htm. 
Registrations fees are as follows: $575.00 for SOCRA members; $650.00 
for nonmembers (includes membership); $450.00 for Federal Government 
members; $525.00 for Federal Government nonmembers; FDA employee rate 
is fee-waived. The registration fee will cover actual expenses 
including refreshments, lunch, materials, and speaker expenses. If you 
need special accommodations due to a disability, please contact Jane 
Kreis (see Contact Person) at least 10 days in advance.

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

[[Page 20665]]

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; and (12) The Inspection is Over--
What Happens Next? Possible FDA Compliance Actions.
    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: The Society of Clinical Research 
Associates is accredited by the Accreditation Council for Continuing 
Medical Education to provide continuing medical education for 
physicians. CNE for Nurses: Society of Clinical Research Associates 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 (ANCC) on 
Accreditation. ANCC/PSNA Provider Reference Number: 205-3-A-09.
    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 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 outreach 
activities by Government agencies to small businesses.

    Dated: April 1, 2013.
Peter Lurie,
Acting Associate Commissioner for Policy and Planning.
[FR Doc. 2013-07894 Filed 4-4-13; 8:45 am]