E9-20340. Industry Exchange Workshop on Food and Drug Administration Drug and Device Requirements; Public Workshop

AGENCY:

Food and Drug Administration, HHS.

ACTION:

Notice of public workshop.

SUMMARY:

The Food and Drug Administration (FDA) Philadelphia District, in cosponsorship with the Society of Clinical Research Associates (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 October 21, 2009, from 8:30 a.m. to 5 p.m. and October 22, 2009, from 8:30 a.m. to 5 p.m.

Location: The public workshop will be held at the Hyatt Regency Pittsburgh International Airport, 1111 Airport Blvd., Pittsburgh, PA 15231, 724-899-1234 or 1-800-233-1234.

Attendees are responsible for their own accommodations. To make reservations at the Hyatt Regency Hotel, contact the Hyatt Regency Hotel.

Contact: Marie Falcone, Food and Drug Administration, U.S. Customhouse, 200 Chestnut St., rm. 900, Philadelphia, PA 19106, 215-717-3703, FAX: [phone], e-mail: [e-mail].

Registration: You are encouraged to register by October 19, 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 in to 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:

Cost of Registration

Affiliation	Fee
FDA Employee	Fee Waived
Government (Non-Member)	$525.00
Non-Government (SoCRA Member)	$575.00
Non-Government (Non SoCRA Member)	$650.00

If you need special accommodations due to a disability, please contact Marie Falcone (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, telephone, fax number, and e-mail address, 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 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 (VISA/MasterCard/AMEX only). For more information on the public workshop, or for questions on registration, contact the Society of Clinical Research Associates 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. The 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 (IRB) inspections, electronic record requirements, and investigator initiated research. Topics for discussion include the following:

• What FDA Expects in a Pharmaceutical Clinical Trial;
• Adverse Event Reporting—Science, Regulation, Error, and Safety;
• Part 11 Compliance—Electronic Signatures;
• Informed Consent Regulations;
• IRB Regulations and FDA Inspections;
• Keeping Informed and Working Together;
• FDA Conduct of Clinical Investigator Inspections;
• Meetings With FDA: Why, When, and How;
• Investigator Initiated Research;
• Medical Device Aspects of Clinical Research;
• Working With FDA's Center for Biologics Evaluation and Research; and
• 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: August 18, 2009.

David Horowitz,

Assistant Commissioner for Policy.