[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]
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