[Federal Register Volume 80, Number 65 (Monday, April 6, 2015)]
[Notices]
[Page 18413]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2015-07810]
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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 Clinical Trial Requirements, Regulations, Compliance and
Good Clinical Practice
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice of public conference.
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SUMMARY: The Food and Drug Administration (FDA) is announcing an
educational conference cosponsored with the Society of Clinical
Research Associates (SOCRA). The public conference regarding 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 including informed consent documents, regulations
relating to drugs, devices, and biologics, as well as inspections of
clinical investigators, IRBs, and research sponsors.
Date and Time: The public conference will be held on May 13 and 14,
2015, from 8 a.m. to 5 p.m.
Location: The conference will be held at The Westin Cincinnati, 21
East Fifth Street, Cincinnati, OH 45202; 513-621-7700. Attendees are
responsible for their own accommodations. Please mention SOCRA to
receive the hotel room rate of $169 plus applicable taxes (available
until April 15, 2015, or until the SOCRA room block is filled).
Contact: John Fraser, Cincinnati District Office, Food and Drug
Administration, 6751 Steger Dr., Cincinnati OH 45237, 513-679-2700,
FAX: 513-679-2771 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:
http://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; Federal
Government nonmember, $525; FDA employee, free (fee waived).
If you need special accommodations due to a disability, please
contact SOCRA (see 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 Continuing Nurse Education (CNE). SOCRA designates this
live activity for a maximum of 13.3 American Medical Association
Physicians Recognition Award Category 1 Credit(s)TM.
Physicians should claim only the credit commensurate with the extent of
their participation. Continuing Medical Education for physicians: SOCRA
is accredited by the Accreditation Council for Continuing Medical
Education to provide continuing medical education for physicians. CNE
for nurses: SOCRA 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 on Accreditation(ANCC). ANCC/PSNA Provider Reference Number:
205-3-A-09.
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 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).
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) The Role of the
FDA District Office Relative to the Bioresearch Monitoring Program; (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 Food and Drug Administration 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: April 1, 2015.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2015-07810 Filed 4-3-15; 8:45 am]
BILLING CODE 4164-01-P