Document ID: FDA-2017-N-4952-0001
Agency: fda
Document Type: Notice
Title: Food and Drug Administration Clinical Trial Requirements, Regulations, Compliance, and Good Clinical Practice; Public Workshop
Posted Date: 2017-09-25T04:00Z

[Federal Register Volume 82, Number 184 (Monday, September 25, 2017)]
[Notices]
[Pages 44625-44626]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2017-20375]

=======================================================================
-----------------------------------------------------------------------

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2017-N-4952]

Food and Drug Administration Clinical Trial Requirements, 
Regulations, Compliance, and Good Clinical Practice; Public Workshop

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice of public workshop.

-----------------------------------------------------------------------

SUMMARY: The Food and Drug Administration (FDA) is announcing an 
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 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 and informed consent 
documents; regulations relating to drugs, devices, and biologics; and 
inspections of clinical investigators, IRBs, and research sponsors.

DATES: The public workshop will be held on November 15 and 16, 2017, 
from 8 a.m. to 5 p.m. See the SUPPLEMENTARY INFORMATION section for 
registration date and information.

ADDRESSES: The public workshop will be held at the Wyndham Lake Buena 
Vista Resort, 1850 Hotel Plaza Blvd., Lake Buena Vista, FL 32830, 407-
828-4444.

FOR FURTHER INFORMATION CONTACT: Kim Prenter, Food and Drug 
Administration, 15100 NW. 67th Ave., Suite 400, Miami Lakes, FL 33014, 
305-816-1474, Fax: 305-816-1536; or Society of Clinical Research 
Associates (SOCRA), 530 West Butler Ave., Suite 109, Chalfont, PA 
18914, 800-762-7292, Fax 215-822-8633, email: SoCRAmail@aol.com, Web 
site: https://www.socra.org.

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 public workshop will provide those engaged in FDA-regulated 
(human) clinical trials with information on a number of topics 
concerning FDA requirements related to clinical investigations, 
informed consent, and inspections of clinical investigators and IRBs.
    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 public 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.

II. Topics for Discussion

    Topics for discussion include the following: (1) What FDA Expects 
in a Pharmaceutical Clinical Trial; (2) Adverse Event Reporting--
Science, Regulation, Error and Safety; (3) Part 11 Compliance--
Electronic Signatures; (4) Informed Consent Regulations; (5) IRB 
Regulations and FDA Inspections; (6) Keeping Informed and Working 
Together; (7) FDA Conduct of Clinical Investigator Inspections; (8) 
Meetings with FDA: Why, When, and How; (9) Investigator Initiated 
Research; (10) Medical Device Aspects of Clinical Research; (11) 
Working with FDA's Center for Biologics Evaluation and Research; and 
(12) The Inspection Is Over--What Happens Next? Possible FDA Compliance 
Actions.

III. Participating in the Public Workshop

    Registration: Attendees are responsible for their own 
accommodations. Please mention SOCRA to receive the hotel room rate of 
$129 plus applicable taxes (available until October 16, 2017, or until 
the SOCRA room block is filled). For additional registration and 
meeting information, visit https://www.socra.org/ or https://www.socra.org/conferences-and-education/live-conferences/fda-clinical-trial-requirements-regulations-compliance-and-gcp-conference/register/.
    Registrations fees are as follows: $575 for SOCRA members, $650 for 
non-members (includes membership), $450 for Federal Government members, 
$525 for Federal Government non-members, and fee waived for FDA 
Employees.
    The registration fee covers expenses including refreshments, lunch, 
materials, and speaker expenses. Registration for the conference is 
open through November 14, 2017.
    If you need special accommodations due to a disability, please 
contact Kim Prenter (see FOR FURTHER INFORMATION CONTACT) at least 10 
days in advance.
    Other Issues for Consideration: Extended periods of question and 
answer and discussion have been included in the program schedule. This 
program offers 13.3 hours of Continuing Medical Education (CME) and 
Continuing Nursing Education (CNE) credit. CME for Physicians: The 
Society of Clinical Research Associates is accredited by the 
Accreditation Council for Continuing Medical Education to provide 
continuing medical education for physicians. CNE for Nurses: The 
Society of Clinical Research Associates is accredited as a provider of 
continuing nursing education by the American Nurses Credentialing 
Center's Commission on Accreditation. ANCC/PSNA Provider Reference 
Number: 205-3-A-09.

[[Page 44626]]

    Dated: September 19, 2017.
Anna K. Abram,
Deputy Commissioner for Policy, Planning, Legislation, and Analysis.
[FR Doc. 2017-20375 Filed 9-22-17; 8:45 am]
BILLING CODE 4164-01-P