[Federal Register Volume 70, Number 181 (Tuesday, September 20, 2005)]
[Notices]
[Pages 55143-55144]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 05-18654]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration


Industry Exchange Workshop on Food and Drug Administration 
Clinical Trials Statutory and Regulatory Requirements

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice of public workshop.

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SUMMARY: The Food and Drug Administration (FDA) Cincinnati District, in 
cooperation with the Society of Clinical Research Associates (SoCRA), 
is announcing a workshop on FDA clinical trial statutory and regulatory 
requirements. This 2-day workshop for the clinical research community 
targets sponsors, monitors, clinical investigators, institutional 
review boards, and those who interact with them for the purpose of 
conducting FDA-regulated clinical research. The workshop will include 
both industry and FDA perspectives on proper conduct of clinical trials 
regulated by FDA.
    Date and Time: The public workshop will be held on Wednesday, 
December 7, 2005, from 8:15 a.m. to 5 p.m. and Thursday, December 8, 
2005, from 8:15 a.m. to 4 p.m.
    Location: The public workshop will be held at The Westin 
Cincinnati, 21 East 5th St., Cincinnati, OH 45202-3160, 513-621-7700, 
FAX: 513-852-5670.
    Contact: Marie Falcone, Food and Drug Administration, rm. 900, U.S. 
Customhouse, 200 Chestnut St., Philadelphia, PA 19106, 215-717-3703, 
FAX: 215-597-5798, e-mail: <a href="/cdn-cgi/l/email-protection#bcd1daddd0dfd3d2d9fcd3cedd92dad8dd92dbd3ca"><span class="__cf_email__" data-cfemail="29444f48454a46474c69465b48074f4d48074e465f">[email protected]</span></a>.
    Registration: Send registration information (including name, title, 
firm name, address, telephone, and fax number), and the registration 
fee of $485 (member), $560 (nonmember), or $460 (government employee 
nonmember) (includes a 1-year membership). The registration fee for FDA 
employees is waived. Make the registration fee payable to SoCRA, P.O. 
Box 101, Furlong, PA 18925. To register via the Internet go to http://www.socra.org/FDA_Conference.htm. (FDA has verified the Web site 
address, but is not responsible for subsequent changes to the Web site 
after this document publishes in the Federal Register.)
    The registrar will also accept payment by major credit cards. For 
more information on the meeting, or for questions on registration, 
contact 800-SoCRA92 (800-762-7292), or 215-345-7749, or FAX: 215-345-
7369, or e-mail: <a href="/cdn-cgi/l/email-protection#fa899599889b979b9396ba9b9596d4999597"><span class="__cf_email__" data-cfemail="6714080415060a060e0b2706080b4904080a">[email protected]</span></a>. Attendees are responsible for their 
own accommodations. To make reservations at The Westin Cincinnati at 
the reduced conference rate, contact The Westin Cincinnati see 
Location) through November 7, 2005, or until the SoCRA room block is 
full.
    The registration fee will be used to offset the expenses of hosting 
the conference, including meals, refreshments, meeting rooms, and 
materials. Space is limited, therefore interested parties are 
encouraged to register early. Limited onsite registration may be 
available. Please arrive early to ensure prompt registration.
    If you need special accommodations due to a disability, please 
contact Marie Falcone at least 7 days in advance of the workshop.

SUPPLEMENTARY INFORMATION: The ``FDA Clinical Trials Statutory and 
Regulatory Requirements'' workshop helps fulfill the Department of 
Health and Human Services' and FDA's important mission to protect the 
public health by educating researchers on proper conduct of clinical 
trials. FDA has made education of the research community a high 
priority to assure the quality of clinical data and protect research 
subjects.
    The workshop helps to implement the objectives of section 903 of 
the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 393) and the FDA 
Plan for Statutory Compliance, which includes working more closely with 
stakeholders and ensuring access to needed scientific and technical 
expertise. The workshop also furthers the goals of the Small Business 
Regulatory Enforcement Fairness Act (Public Law 104-121) by providing 
outreach activities by Government agencies directed to small 
businesses.
    The following topics will be discussed at the workshop:
    <bullet> FDA and confidence in the conduct of clinical research;
    <bullet> Medical device, drug, and biological product aspects of 
clinical research;
    <bullet> Investigator initiated research;
    <bullet> Pre-investigational new drug application (IND) meetings 
and FDA meeting process;
    <bullet> Informed consent requirements;
    <bullet> Ethics in subject enrollment;
    <bullet> FDA regulation of Institutional Review Boards;
    <bullet> Electronic records requirements;
    <bullet> Adverse event reporting;
    <bullet> How FDA conducts bioresearch inspections; and
    <bullet> What happens after the FDA inspection.


[[Page 55144]]


    Dated: September 12, 2005.
Jeffrey Shuren,
Assistant Commissioner for Policy.
[FR Doc. 05-18654 Filed 9-19-05; 8:45 am]
BILLING CODE 4160-01-S


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