E9-12051. Food and Drug Administration Clinical Trial Requirements; Public Workshop

AGENCY:

Food and Drug Administration, HHS.

ACTION:

Notice of public workshop.

SUMMARY:

The Food and Drug Administration (FDA) Minneapolis District, in cosponsorship with the Society of Clinical Research Associates, Inc. (SoCRA) is announcing a public workshop entitled “FDA Clinical Trial Requirements.” This 2-day public workshop is intended to provide information about FDA clinical trial requirements to the regulated industry.

Date and Time: The public workshop will be held on Wednesday, June 10, 2009, from 8:30 a.m. to 5 p.m., and Thursday, June 11, 2009, from 8:30 a.m. to 5 p.m.

Location: The public workshop will be held at the Radisson University Hotel, Suite 600, 615 Washington Ave., SE., Minneapolis, MN 55414, 612-379-8888 or 1-800-822-6757 or 888-201-1718.

Contact: Carrie Hoffman, Food and Drug Administration, 250 Marquette Ave., Minneapolis, MN 55401, 612-758-7200, FAX: [phone], e-mail: [e-mail].

Attendees are responsible for their own accommodations. To make reservations at the Radisson University Hotel, contact the Radisson University Hotel (see Location).

Registration: You are encouraged to register by June 9, 2009. The SoCRA registration fees cover the cost of facilities, materials, and breaks. Seats are limited; please submit your registration as soon as possible. Course space will be filled in order of receipt of registration. Those accepted into the course will receive confirmation. Registration will close after the course is filled. Registration at the site is not guaranteed but may be possible on a space available basis on the day of the public workshop beginning at 8 a.m. The cost of registration is as follows: FDA employee (fee waived), Government employee nonmember ($525), non-Government employee SoCRA member ($575), non-Government employee non-SoCRA member ($650).

If you need special accommodations due to a disability, please contact Carrie Hoffman (see Contact) at least 7 days in advance of the workshop.

Registration Instructions: To register, please submit a registration form with your name, affiliation, mailing address, phone, fax number, and e-mail, along with a check or money order payable to “SoCRA.” Mail to: SoCRA, 530 West Butler Ave., Suite 109, Chalfont, PA 18914. To register via the Internet, go to http://www.socra.org/​html/​FDA_​Conference.htm. (FDA has verified the Web site address, but we are not responsible for any subsequent changes to the Web site after this document publishes in the Federal Register.)

The registrar will also accept payment by major credit cards (VISA/MasterCard/AMEX only). For more information on the meeting, or for questions on registration, contact SoCRA at 800-762-7292 or 215-822-8644, FAX: [phone], or e-mail: [e-mail].

SUPPLEMENTARY INFORMATION:

The public workshop helps fulfill the Department of Health and Human Services' and FDA's important mission to protect the public health. 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; (12) The Inspection is Over—What Happens Next? Possible FDA Compliance Actions.

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 FDA 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: May 18, 2009.

Jeffrey Shuren,

Associate Commissioner for Policy and Planning.