82 FR 11043 - Food and Drug Administration/Xavier University PharmaLink Conference-Leadership in a Global Supply Chain

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration

Federal Register Volume 82, Issue 32 (February 17, 2017)

The Food and Drug Administration (FDA) Cincinnati District, in co-sponsorship with Xavier University, is announcing a public conference entitled ``FDA/Xavier University PharmaLink Conference: Leadership in a Global Supply Chain.'' 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 and industry experts.

[Federal Register Volume 82, Number 32 (Friday, February 17, 2017)]
[Notices]
[Pages 11043-11044]
From the Federal Register Online  [www.thefederalregister.org]
[FR Doc No: 2017-03176]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2017-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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SUMMARY: The Food and Drug Administration (FDA) Cincinnati District, in 
co-sponsorship with Xavier University, is announcing a public 
conference entitled ``FDA/Xavier University PharmaLink Conference: 
Leadership in a Global Supply Chain.'' 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 and industry experts.

DATES: The public conference will be held on March 15, 2017, from 8:30 
a.m. to 5 p.m.; March 16, 2017, from 8:30 a.m. to 5 p.m.; and March 17, 
2017, from 8:30 a.m. to 12:20 p.m. The conference is preceded by a 
Welcome Reception on March 14, 2017, from 5 p.m. to 7 p.m. See the 
SUPPLEMENTARY INFORMATION section for registration date and 
information.

ADDRESSES: The public conference will be held on the campus of Xavier 
University, 3800 Victory Pkwy., Cincinnati, OH 45207, 513-745-3073 or 
513-745-3483.

FOR FURTHER INFORMATION CONTACT: 
    For information regarding this notice: Nicholas Paulin, Food and 
Drug Administration, Cincinnati South Office, 36 East 7th St., 
Cincinnati, OH 45202, 513-246-4134, email: [email protected].
    For information regarding the conference and registration: Marla 
Phillips, Xavier University, 3800 Victory Pkwy., Cincinnati, OH 45207-
5471, 513-745-3073, email: [email protected].

SUPPLEMENTARY INFORMATION: 

I. Background

    The public conference helps fulfill the Department of Health and 
Human Services' and FDA's important mission to protect the public 
health. The most pressing challenges of the global pharmaceutical 
industry require solutions which are inspired by collaboration to 
ensure the on-going health and safety of patients. These challenges 
include designing products with the patient in mind, building quality 
into the product from the starting point, selecting the right 
suppliers, and considering total product lifecycle 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.
    The conference includes the following:
     Welcome Reception at the Hilton Netherland Plaza.
     Lunch Networking by Topic.
     The Solution ``Xchange''.
     Case Studies and Small Group Discussions.
     Action Plans.

II. Topics for Discussion at the Public Conference

    The public conference will engage those involved in FDA-regulated 
global supply chain quality and management through the following 
topics:
     FDA Metrics Program--Path Forward to Reduce Risks Within 
FDA and Across Industry.
     Predictive Capabilities Through a Living Metrics Model.
     How Big Data and Artificial Intelligence Can Enhance Your 
Proactive Risk Monitoring Programs.
     Connecting Culture to Performance.
     Data Integrity--Detection and Successful Practices.
     Building a Bridge Across Generations.
     Good Supply Practices (GSPs)--Paradigm Shifting Solutions.
     How to Develop and Execute a Robust Risk-Based Due 
Diligence Plan.
     Maximizing Post-Merger Success.
     Your Company Bought a New Business--Now What?
     Supply Chains in China--Strategies for Regulatory Success.
     Top 3 Challenges for Successful Serialization 
Implementation Across Your Supply Chain.
     Strategic Direction of the Food & Drug Administration, 
Center for Drug Evaluation and Research (CDER), Office of Manufacturing 
Quality.
     Office of Regulatory Affairs Key Initiatives.
     FDA Investigator Case Study Insights.

III. Registration for the Public Conference

    Registration: To register online for the public conference, please 
visit the ``Registration'' link on the conference Web site at http://www.XavierPharmaLink.com. Please provide complete contact information 
for each attendee, including name, title, affiliation, address, email, 
and telephone. FDA has verified the Web site address in this document, 
as of the date this document publishes in the Federal Register, but Web 
sites are subject to change over time.
    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: Marla Phillips, 3800 Victory 
Pkwy., Cincinnati, OH 45207-5471. An email will be sent confirming your 
registration.
    If you need special accommodations due to a disability, please 
contact Marla Phillips (see FOR FURTHER INFORMATION CONTACT) at least 7 
days in advance of the conference.
    There is a registration fee. The conference registration fees cover 
the cost of the presentations, training materials, receptions, 
breakfasts, lunches, and dinners for the 2.5 days of the conference, 
including the Welcome Reception that precedes the conference. There 
will be onsite registration if space is available. The cost of 
registration is as follows:

                     Table 1--Registration Fees \1\
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                                                               Standard
                       Attendee type                             rate
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Industry...................................................       $1,895
Small Business (<100 employees)............................        1,295
Start-up Manufacturer......................................          300
Academic...................................................          300
Media......................................................         Free

[[Page 11044]]

 
Government.................................................         Free
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\1\ The fourth registration from the same company is free. Payment for
  the three paying registrants must be made prior to registering the
  fourth person free.

The following forms of payment will be accepted: American Express, 
Visa, Mastercard, and company checks.
    Attendees are responsible for their own accommodations. The 
conference headquarter hotel is the Downtown Cincinnati Hilton 
Netherlands Plaza, 35 West 5th St., 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.

    Dated: February 13, 2017.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2017-03176 Filed 2-16-17; 8:45 am]
 BILLING CODE 4164-01-P