
[Federal Register Volume 79, Number 32 (Tuesday, February 18, 2014)]
[Notices]
[Page 9229]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2014-03454]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2014-N-0001]


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

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice of public conference.

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    The Food and Drug Administration (FDA) Cincinnati District, in 
cosponsorship with Xavier University, is announcing a public conference 
entitled ``FDA/Xavier University PharmaLink Conference: Leadership in a 
Global Supply Chain.'' The public 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 to create synergies focused on 
finding solutions which make a difference. The experience level of the 
audience has fostered engaged dialog that has led to innovative 
initiatives.
    Dates and Times: The public conference will be held on March 19 and 
20, 2014, from 8:30 a.m. to 5 p.m. and March 21, 2014, from 8:30 a.m. 
to 12:15 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 513-745-3020.
    Contact Persons:
    For information regarding this notice: Steven Eastham, Food and 
Drug Administration, Cincinnati South Office, 36 East 7th Street, 
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.
    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. There will be onsite registration. The cost of 
registration is as follows:

                     Table1.--Registration Fees \1\
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                                                           Registration
                      Attendee type                            fees
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Industry................................................          $1,895
Small Business (<100 employees).........................          $1,295
Startup Manufacturer....................................            $300
Academic................................................            $300
Media...................................................            Free
Government..............................................            Free
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\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: Matty Toomb, 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 sellout 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 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 engage those involved in 
FDA-regulated global supply chain quality and management through the 
following topics:

     The Impact of ``The CDER Challenge'' to Industry
     FDA and the Medicines and Healthcare Products Regulatory 
Agency (MHRA) Investigator Insights
     Operationalizing Effective Contract Partnerships
     Comparing Metrics with Other Companies--is There a Way? 
Why is it Vital?
     Complex Supply Chain Development
     The FDA Safety and Innovation Act (FDASIA): The New 
Frontier
     Why Your Incoming Supply is Not Reliable--Shifting 
Paradigms
     Innovation Versus Safety--The Impact of the Center for 
Drug Evaluation and Research's Restructure
     MHRA Perspective on Global Supply Chain Challenges
     How Did They Do That? Learn from Other Industries!
    The conference includes:
     Networking by topic
     Case studies
     Small group discussions
     Action plans
     Keynote dinner at the Cincinnati Reds Baseball Stadium 
with the Chief Executive Officer of Patheon, James Mullen
    The most pressing challenges of the global pharmaceutical industry 
require solutions which are inspired by collaboration to ensure the 
ongoing health and safety of 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 the job 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 (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 12, 2014.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2014-03454 Filed 2-14-14; 8:45 am]
BILLING CODE 4160-01-P


