[Federal Register: May 28, 2003 (Volume 68, Number 102)]
[Notices]
[Page 31720-31721]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr28my03-65]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
FDA/Industry Exchange Workshop on FDA Clinical Trials Statutory
and Regulatory Requirements; Public Workshop
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice of public workshop.
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SUMMARY: The Food and Drug Administration (FDA) Philadelphia District,
in cooperation with the Society of Clinical Research Associates,
(SoCRA) is announcing a workshop on FDA clinical trial statutory and
regulatory requirements. Topics for discussion include: Financial
incentives and funding, pre-IND (investigational new drug application)
meetings and FDA meeting process, medical device aspects of clinical
research, informed consent requirements, adverse event reporting, how
FDA conducts bioresearch inspections, ethics in clinical research, FDA
and confidence in the conduct of clinical research, and how FDA
addresses fraud in clinical research. 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 is scheduled for Wednesday, June
25, 2003, from 8:30 a.m. to 4:45 p.m. and Thursday, June 26, 2003, from
8:45 a.m. to 4:45 p.m.
Location: The public workshop will be held at the Pittsburgh
Marriott Center City Hotel, 112 Washington Pl., Pittsburgh, PA 15219.
Contact: Daniel R. Tammariello, FDA, 7 Parkway Center, Suite 250,
Pittsburgh, PA 15220, 412-644-3394, ext. 16, FAX: 412-644-4496, e-mail:
dtammari@ora.fda.gov or Marie Falcone, Industry and Small Business
Representative, FDA, Room 900 U.S. Customhouse, 200 Chestnut St.,
[[Page 31721]]
Philadelphia, PA 19106, 215-597-2120, ext. 4003, FAX: 215-597-5798, e-
mail: mfalcone@ora.fda.gov. Registration: Send registration information (including name, title,
firm name, address, telephone, and fax number) and $460 (member) or
$535 (non-member) registration fee made 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.
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 215-345-7369 or via e-mail to
socramail@aol.com. Attendees are responsible for their own
accommodations. To make reservations at the Pittsburgh Marriott Center
City Hotel at the reduced conference rate, contact the Pittsburgh
Marriott Center City Hotel at 412-471-4000 or 888-456-6600 or by fax at
hotel FAX: 412-281-4797 before June 3, 2003.
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 406 of
the FDA Modernization 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.
Dated: May 20, 2003.
Jeffrey Shuren,
Assistant Commissioner for Policy.
[FR Doc. 03-13192 Filed 5-27-03; 8:45 am]
BILLING CODE 4160-01-S