E9-30017. Food and Drug Administration Clinical Trial Requirements, Regulations, Compliance and Good Clinical Practices; Public Workshop

AGENCY:

Food and Drug Administration, HHS.

ACTION:

Notice of public workshop.

SUMMARY:

The Food and Drug Administration (FDA) Florida District, in cosponsorship with The Society of Clinical Research Associates, Inc. (SoCRA), is announcing a public workshop entitled “FDA Clinical Trial Requirements, Regulations, Compliance and GCP.” 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, March 3, 2010, from 8 a.m. to 5 p.m., and Thursday, March 4, 2010, from 8 a.m. to 4:35 p.m.

Location: The public workshop will be held at The Wyndham Orlando Resort, 8001 International Dr., Orlando, FL 32819, 407-351-2420.

Attendees are responsible for their own accommodations. To make reservations at the Wyndham Orlando Resort, at the discounted rate of $149 per night (plus applicable taxes), contact the hotel before February 10, 2010, citing “SoCRA”. The hotel's Web site is: http://www.wyndham.com/​hotels/​MCOWD/​main.wnt. (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.)

Contacts:

For FDA: C. Stewart Watson, Food and Drug Administration, 555 Winderley Pl., suite 200, Maitland, FL 32751, 407-475-4756, FAX: [phone], e-mail: [e-mail].

For SoCRA: SoCRA Administrative Office, 530 West Butler Ave., suite 109, Chalfont, PA 18914, 1-800-762-7292 or 215-822-8644, FAX: [phone], e-mail: [e-mail].

Registration: You are encouraged to register by February 26, 2010. Seats are limited; please submit your registration as soon as possible. Workshop space will be filled in order of receipt of registration. Registration will close when the workshop is filled. Those accepted into the workshop will receive confirmation. 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 SoCRA registration fees cover the cost of the workshop facilities, materials, breaks, and lunches. The cost of registration is as follows:

Cost of Registration

Affiliation	Fee
FDA Employee	Fee waived
Federal Government (SoCRA Member)	$450.00
Federal Government (Non-SoCRA Member)	$525.00
Non-Federal Government (SoCRA Member)	$575.00
Non-Federal Government (Non-SoCRA Member)	$650.00

If you need special accommodations due to a disability, please contact C. Stewart Watson at least 7 days in advance of the meeting.

Registration instructions: To register, please submit your name, affiliation, mailing address, phone/fax number, and e-mail, along with a check or money order payable to SoCRA. Please mail your payment to: SoCRA Administrative Office, 530 West Butler Ave., suite 109, Chalfont, PA 18914. Registration may be downloaded on the SoCRA Web site at http://www.socra.org. (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.)

Other payment forms accepted are major credit cards (VISA, MasterCard, or American Express only). For more information on the meeting, or for questions on registration, contact the SoCRA Administrative Office (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 public 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 investigations, electronic record requirements, and investigator initiated research. Topics for discussion include the following: (1) What FDA Expects in a Pharmaceutical Clinical Trial, (2) Adverse Event Reporting, (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 the FDA, (9) Investigator Initiated Research, (10) Medical Device Aspects of Clinical Research, (11) Working with FDA's Center for Biologics Evaluation and Research, (12) Ethical Issues in Subject Enrollment, (13) 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 public 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 public workshop also is consistent with the Small Business Regulatory Enforcement Fairness Act of 1996 (Public Law 104-121), as outreach activities by Government agencies to small businesses.

Dated: December 10, 2009.

David Horowitz,

Assistant Commissioner for Policy.