[Federal Register Volume 80, Number 31 (Tuesday, February 17, 2015)]
[Notices]
[Pages 8325-8326]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2015-03118]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2015-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 Public Workshop.

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SUMMARY: The Food and Drug Administration (FDA) is announcing the 
following conference: Educational Conference co-sponsored with the 
Society of Clinical Research Associates (SOCRA). The public workshop 
FDA's clinical trial requirements is designed to aid the Clinical 
Research Professional's understanding of the mission, responsibilities 
and authority of the FDA and to facilitate interaction with FDA 
representatives. The program will focus on the relationships among the 
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

[[Page 8326]]

clinical investigators, of IRB, and of research sponsors.
    Date and Time: The conference will be held on March 11 and 12, 
(Wednesday and Thursday) 2015, from 8:00 a.m. to 5 p.m.
    Location: The conference will be held at the Holiday Inn Golden 
Gateway Hotel, 1500 Van Ness Ave., San Francisco, CA 91409, 415-441-
4000.
    Attendees are responsible for their own accommodations. Please 
mention SOCRA to receive the hotel room rate of $159.00 plus applicable 
taxes (available until February 13, 2015, or until the SOCRA room block 
is filled).
    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 or 215-822-
8644, FAX: 215-822-8633, email: [email protected] Web site: 
www.socra.org. (FDA has verified the Web site addresses throughout this 
document, but we are not responsible for any subsequent changes to the 
Web sites after this document publishes in the Federal Register).
    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 nonmember--$525.00, FDA Employee--(free) Fee Waived.
    If you need special accommodations due to a disability, please 
contact SOCRA (see Contact Person) 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 Credits for SOCRA 
continuing education (CE) and Nurse continuing nurse education (CNE), 
SOCRA designates this live activity for a maximum of 13.3 American 
Medical Association Physician's Recognition Award Category 1 
Credit(s)TM. Physicians should claim only the credit 
commensurate with the extent of their participation. Continuing medical 
education (CME) for Physicians: SOCRA is accredited by the 
Accreditation Council for Continuing Medical Education to provide CME 
for physicians. CNE for Nurses: Society of Clinical Research Associates 
is accredited as a provider of continuing nursing education by the 
American Nurses Credentialing Center's Commission on Accreditation.
    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 Person for address). 
To register via the Internet, go to http://www.socra.org/html/FDA_Conference.htm. 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 Person).

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 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 the 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 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: February 10, 2015.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2015-03118 Filed 2-13-15; 8:45 am]
BILLING CODE 4164-01-P