[Federal Register Volume 80, Number 17 (Tuesday, January 27, 2015)]
[Notices]
[Pages 4289-4290]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2015-01418]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2015-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 
cosponsorship 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, 
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 25, 
2015, from 8:30 a.m. to 5 p.m.; March 26, 2015, from 8:30 a.m. to 5 
p.m.; and March 27, 2015, from 8:30 a.m. to 12:45 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: 
<a href="/cdn-cgi/l/email-protection#7e0d0a1b081b10501b1f0d0a161f133e181a1f5016160d50191108"><span class="__cf_email__" data-cfemail="99eaedfceffcf7b7fcf8eaedf1f8f4d9fffdf8b7f1f1eab7fef6ef">[email protected]</span></a>.
    For information regarding the conference and registration: Marla 
Phillips, Xavier University, 3800 Victory Pkwy., Cincinnati, OH 45207-
5471, 513-745-3073, email: <a href="/cdn-cgi/l/email-protection#1f6f77767373766f6c722b5f677e69767a6d317a7b6a"><span class="__cf_email__" data-cfemail="09796160656560797a643d4971687f606c7b276c6d7c">[email protected]</span></a>.
    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:

                                         Table 1--Registration Fees \1\
----------------------------------------------------------------------------------------------------------------
                                                  Early rate (on or   Advanced rate (1/25/  Standard rate (after
                 Attendee type                     before 1/24/15)       15 to 2/24/15)           2/24/15)
----------------------------------------------------------------------------------------------------------------
Industry......................................                $1,295                $1,695                $1,895
Small Business (<100 employees)...............                   995                 1,195                 1,295
Startup Manufacturer..........................                   200                   250                   300
Academic......................................                   200                   250                   300
Media.........................................                  Free                  Free                  Free
Government....................................                  Free                  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: Mason Rick, 3800 Victory 
Pkwy., Cincinnati, OH 45207-5471. 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:

<bullet> Major Changes at FDA Affecting You
<bullet> FDA-Driven Initiatives through Food and Drug Administration 
Safety and Innovation Act Implementation
<bullet> Held at the Border? Understand Why
<bullet> Toyota Production System--Cultural Requirements
<bullet> Barriers to Quality and Supply Chain Excellence
<bullet> Establishing Good Supply Practices
<bullet> Medicines and Healthcare Products Regulatory Agency 
Perspective on Global Supply Chain Challenges
<bullet> Systematic Approach to Managing Your Global Supply Chain
<bullet> Deep Dive Lunch Session--Clinically Relevant Metrics
<bullet> Deep Dive Lunch Session--Data Integrity: How To Verify You Are 
Okay
<bullet> Deep Dive Lunch Session--Integrity of Supply Workshop
<bullet> Nobel Prize-Based Alignment Optimization

[[Page 4290]]

<bullet> Quality Metrics Beyond Compliance To Drive Strategic Value
<bullet> Risk Categorization of Your Company
<bullet> Challenges That Lie Outside U.S. Borders
<bullet> Global Supply Chain Risk Management Case Studies
<bullet> FDA Investigator Insights

    The conference includes:

<bullet> Networking by topic
<bullet> Case studies
<bullet> Small group discussions
<bullet> Action plans
<bullet> Keynote dinner at the Newport Aquarium

    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 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.

    Dated: January 21, 2015.
Leslie Kux,
Associate Comissioner for Policy.
[FR Doc. 2015-01418 Filed 1-26-15; 8:45 am]
BILLING CODE 4164-01-P


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