[Federal Register Volume 81, Number 30 (Tuesday, February 16, 2016)]
[Notices]
[Pages 7802-7803]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2016-02965]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2016-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.
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SUMMARY: The Food and Drug Administration (FDA) is announcing the
following public workshop entitled ``Educational Conference Co-
Sponsored With the Society of Clinical Research Associates (SOCRA).''
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, 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, of IRBs, and of research sponsors.
DATES: The public workshop will be held on March 9 and 10, 2016, from 8
a.m. to 5 p.m.
ADDRESSES: The public workshop will be held at the Holiday Inn San
Diego Bayside, 4875 North Harbor Dr., San Diego, CA 92106, 619-224-
3621.
FOR FURTHER INFORMATION CONTACT: 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,
telephone: 800-762-7292 or 215-822-8644, FAX: 215-822-8633,
[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.)
SUPPLEMENTARY INFORMATION:
I. Background
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, IRB inspections, electronic record
requirements, and investigator initiated research.
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 include 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.
II. Topics for Discussion at the Public Workshop
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; (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 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; and (16) Question and Answer
Session/Panel Discussion.
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, Federal
[[Page 7803]]
Government nonmember--$525, and FDA Employee--(free) Fee Waived.
Attendees are responsible for their own accommodations. Please
mention SOCRA to receive the hotel room rate of $142 plus applicable
taxes (available until the SOCRA room block is filled).
If you need special accommodations due to a disability, please
contact SOCRA (see FOR FURTHER INFORMATION CONTACT) 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 (CE) Credits for
SOCRA CE and Nurse CNE; SOCRA designates this live activity for a
maximum of 13.3 AMA PRA Category 1 Credit(s)TM. Physicians
should claim only the credit commensurate with the extent of their
participation. CME for Physicians: SOCRA 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 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 FOR FURTHER INFORMATION
CONTACT). To register via the Internet, go to http://www.socra.org/html/FDAConference.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 FOR
FURTHER INFORMATION CONTACT).
Dated: February 9, 2016.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2016-02965 Filed 2-12-16; 8:45 am]
BILLING CODE 4164-01-P