2010-9795. Food and Drug Administration/Xavier University Global Outsourcing Conference

AGENCY:

Food and Drug Administration, HHS.

ACTION:

Notice of public conference.

SUMMARY:

The Food and Drug Administration (FDA), Cincinnati District, in co-sponsorship with Xavier University, is announcing a public conference entitled “FDA/Xavier University Global Outsourcing Conference.” This 3-day public conference for the pharmaceutical industry includes presentations from key FDA officials, global regulators, and industry experts. The conference will focus on global compliance challenges associated with pharmaceutical outsourcing relationships and supply chain control, as well as expectations from global regulators. Pharmaceutical companies and contract organizations are invited to this conference to address the issues that reside on both sides. In addition to expert presentations, participants will be engaged through live polling and a small group discussion session on sharing best practices with each other.

Dates and Times: The public conference will be held on June 14 and 15, 2010, from 8 a.m. to 5 p.m. and June 16, 2010, from 8 a.m. to 1 p.m.

Location: The public conference will be held on the campus of Xavier University, 3800 Victory Pkwy., Cincinnati, OH 45207, 513-745-3073 or 513-745-3396.

Contact Persons:

For information regarding this notice: Steven Eastham, Food and Drug Administration, 6751 Steger Dr., Cincinnati, OH 45237, 513-679-2700, ext. 123, e-mail: [e-mail].

For information regarding the conference and registration: Marla Phillips, Xavier University, 3800 Victory Pkwy., Cincinnati, OH 45207, 513-745-3073, e-mail: [e-mail].

Registration: There is a registration fee. The conference registration fees cover the cost of the presentations, training materials, receptions, breakfasts, lunches, dinners, and dinner speakers for the 3 days of the conference. Early registration ends May 14, 2010. Standard registration ends June 13, 2010. There will be onsite registration. The cost of registration is as follows:

Table 1.—Registration Fees¹

Attendees	Fees by May 14th	Fees by June 13th
Industry	$995	$1,200
Small Business (< 100 employees)	$800	$1,000
Academic/Government	$600	$700
Student	$200	$250
FDA Employee	Fee waived	Fee waived
1 The fourth registration from the same company is free.

The following forms of payment will be accepted: American Express, Visa, Mastercard, and company checks.

To register online for the public conference, please visit the “Registration” link on the conference Web site at http://www.XavierGOC.com. (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.)

To register by mail, please send your name, title, firm name, address, telephone and fax numbers, e-mail, and payment information for the fee to Xavier University, Attn: Sue Bensman, 3800 Victory Pkwy., Cincinnati, OH 45207. An e-mail will be sent confirming your registration.

Attendees are responsible for their own accommodations. The conference headquarter hotel is the Downtown Cincinnati Hilton Netherlands Plaza, 35 West 5th Street, Cincinnati, OH 45202, 513-421-9100. To make reservations online, please visit the “Venue/Logistics” link at http://www.XavierGOC.com.

If you need special accommodations due to a disability, please contact Marla Phillips (see Contact Persons) at least 7 days in advance of the conference.

SUPPLEMENTARY INFORMATION:

The public conference helps fulfill the Department of Health and Human Services and FDA's important mission to protect the public health. The conference will provide those engaged in FDA-regulated outsourcing with information on the following topics:

• FDA Center to present on initiatives from Congress and FDA, and resulting impact;
• Global regulator perspective on global compliance initiatives, challenges, and expectations;
• FDA Field perspective on the most common and significant deficiencies specific to outsourcing relationships;
• Global compliance of manufacturing in Asia;
• Pharmaceutical companies—how to manage varying global regulatory expectations while working with contractors in various states of compliance;
• Contract organizations—compliance strategy for managing global regulatory requirements while managing multiple client expectations;
• Contract Organization Selection Process;
• The Client Selection Process—the criteria a contract organization should use to consider saying no to a contract relationship;
• Regulatory challenges—Drug Master File Fitness;
• Due diligence audit—how to audit in 1 day;
• Quality Agreement Development throughout the product and process lifecycle;
• Supply Chain Transparency and Pedigree;
• How to Audit the Supply Chain;
• Rx-360 and International Pharmaceutical Excipients Council initiatives—impact to industry;
• Risk-based Performance Management best practices;
• International Conference on Harmonisation Triple Q's (Q8, Q9, and Q10)—how quality can drive down the cost of business, and how innovation can increase business opportunities;
• Rebuilding the Trust case studies; and
• Small group discussion on sharing best practices.

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 conference helps to achieve objectives set forth in section 406 of the Food and Drug Administration 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 conference also is consistent with the Small Business Regulatory Enforcement Fairness Act of 1996 (Public Law 104-121) by providing outreach activities by Government agencies to small businesses.

Dated: April 22, 2010.

Leslie Kux,

Acting Assistant Commissioner for Policy.