Document ID: FDA-2013-N-0001-0005
Agency: fda
Document Type: Notice
Title: Food and Drug Administration/Xavier University PharmaLink Conference--Quality in a Global Supply Chain
Posted Date: 2013-02-11T05:00Z

[Federal Register Volume 78, Number 28 (Monday, February 11, 2013)]
[Notices]
[Pages 9703-9704]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2013-03018]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2013-N-0001]

Food and Drug Administration/Xavier University PharmaLink 
Conference--Quality in a Global Supply Chain

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 
cosponsorship with Xavier University, is announcing a public conference 
entitled ``FDA/Xavier University PharmaLink Conference.'' The 
PharmaLink conference seeks solutions to important and complicated 
issues by aligning with the strategic priorities of FDA, and includes 
presentations from key FDA officials, global regulators, and industry 
experts. Each presentation challenges the status quo and conventional 
wisdom of our industry to create synergies focused on finding solutions 
which make a difference. Every discussion, exploration, and solution is 
framed by the goal of delivering increased patient health and safety 
through topics such as a working session with the Office of the 
Commissioner on the implementation of the FDA Safety and Innovation 
Act, Business Impact of Outsourcing, Supplier Management Models that 
Work, Implementing Quality by Design (QbD) Successfully--like other 
industries, lunch with global regulators (FDA, Medicines and Healthcare 
products Regulatory Agency (MHRA), Fimea, and Swissmedic), and many 
more. The experience level of our audience has fostered engaged dialog 
that has led to innovative initiatives.

DATES: The public conference will be held on March 12, 2013, from 8:30 
a.m. to 5 p.m.; March 13, 2013, from 8:30 a.m. to 5 p.m.; and March 14, 
2013, from 8:30 a.m. to 12:45 p.m.

ADDRESSES: 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.

FOR FURTHER INFORMATION CONTACT:
     For information regarding this notice: Steven Eastham, Office of 
Regulatory Affairs, Food and Drug Administration, Cincinnati South 
Office, 36 East 7th Street, suite 1910, Cincinnati, OH 45202, 513-246-
4134, email: steven.eastham@fda.hhs.gov.
    For information regarding the conference and registration: Marla 
Phillips, Xavier University, 3800 Victory Pkwy., Cincinnati, OH 45207, 
513-745-3073, email: phillipsm4@xavier.edu.

SUPPLEMENTARY INFORMATION: 
    Registration: There is a registration fee. The conference 
registration fees cover the cost of the presentations, training 
materials, receptions, breakfasts, lunches, and dinners for the 2\1/2\ 
days of the conference. Advanced registration rate ends February 18, 
2013. Standard registration rates begin on February 19, 2013. There 
will also be onsite registration. The cost of registration is as 
follows:

                     Table 1--Registration Fees \1\
------------------------------------------------------------------------
      Attendee type           Fee Jan. 23-Feb. 18      Fee after Feb. 18
------------------------------------------------------------------------
          Industry                     $1,295            $1,495
Small Business (<100                      900             1,000
         employees)
       Consultants                        600               700
Startup Manufacturer                      250               300
          Academic                        250               300
             Media                       Free              Free
        Government                       Free              Free
------------------------------------------------------------------------
\1\ The fourth registration from the same company is free--all four
  attendees must register at the same time.

    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.XavierPharmaLink.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, email, and payment information for 
the fee to Xavier University, Attention: Susan Bensman, 3800 Victory 
Pkwy., Cincinnati, OH 45207. An email 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.XavierPharmaLink.com. The hotel is 
expected to sell out during this timeframe, so early reservation in the 
conference room block is encouraged.
    If you need special accommodations due to a disability, please 
contact Marla Phillips (see FOR FURTHER INFORMATION

[[Page 9704]]

CONTACT) at least 7 days in advance of the conference.
    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 engage those involved in FDA-regulated 
global supply chain quality and management through the following 
topics:

 Beyond our Borders--Maximizing the Impact of FDA's Global 
Interactions
 MHRA, Fimea, and Swissmedic--Driving Safety and Innovation
 Food and Drug Administration Safety and Innovation Act--Be 
Part of the Solution, and How do we Measure the Effectiveness of the 
Resulting Change
 Track and Trace in a Global Market
 How do we Gain Greater Supply Chain Visibility?
 Supplier Management Models that Work
 Implementing QbD like Other Industries--Proven Success
 How to Avoid Drug Shortages in your Company
 Pfizer Business Model: Quantitating Culture
 Outsourcing: Business Impact
 FDA, MHRA, and Fimea Inspection Trends and Expectations

    The conference includes:

 Lunch with the Regulators--Facilitated, Interactive Session
 Networking by Topic
 Case Studies
 Small Group Discussions
 Innovation Session Engaging the Audience
 Keynote Dinner at the Cincinnati Art Museum with Chairman, 
CEO, and President of Eli Lilly and Chairman of the Board of PhRMA--
John Lechleiter

    The most pressing challenges of the global pharmaceutical industry 
require solutions which are inspired by collaboration to ensure the 
ongoing health and safety of our patients. These challenges include 
designing products with the patient in mind, building quality into the 
product from the onset, selecting the right suppliers, and considering 
total product life-cycle systems. Meeting these challenges requires 
vigilance, innovation, supply chain strategy, relationship management, 
proactive change management, and a commitment to doing our jobs right 
the first time.
    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 (Public Law 105-115) (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 (Pub. L. 104-121) by providing outreach activities by 
Government Agencies to small businesses.

    Dated: February 6, 2013.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2013-03018 Filed 2-8-13; 8:45 am]
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