[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