[Federal Register Volume 75, Number 81 (Wednesday, April 28, 2010)]
[Notices]
[Pages 22412-22413]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2010-9795]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2010-N-0001]


Food and Drug Administration/Xavier University Global Outsourcing 
Conference

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice of public conference.

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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

[[Page 22413]]

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: [email protected].
    For information regarding the conference and registration: Marla 
Phillips, Xavier University, 3800 Victory Pkwy., Cincinnati, OH 45207, 
513-745-3073, e-mail: [email protected].
    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 Fees\1\
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        Attendees             Fees by May 14th        Fees by June 13th
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Industry                  $995                      $1,200
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Small Business (< 100     $800                      $1,000
 employees)
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Academic/Government       $600                      $700
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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.
[FR Doc. 2010-9795 Filed 4-27-10; 8:45 am]
BILLING CODE 4160-01-S