[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:
[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].
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\
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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)
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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
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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: 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:
Major Changes at FDA Affecting You
FDA-Driven Initiatives through Food and Drug Administration
Safety and Innovation Act Implementation
Held at the Border? Understand Why
Toyota Production System--Cultural Requirements
Barriers to Quality and Supply Chain Excellence
Establishing Good Supply Practices
Medicines and Healthcare Products Regulatory Agency
Perspective on Global Supply Chain Challenges
Systematic Approach to Managing Your Global Supply Chain
Deep Dive Lunch Session--Clinically Relevant Metrics
Deep Dive Lunch Session--Data Integrity: How To Verify You Are
Okay
Deep Dive Lunch Session--Integrity of Supply Workshop
Nobel Prize-Based Alignment Optimization
[[Page 4290]]
Quality Metrics Beyond Compliance To Drive Strategic Value
Risk Categorization of Your Company
Challenges That Lie Outside U.S. Borders
Global Supply Chain Risk Management Case Studies
FDA Investigator Insights
The conference includes:
Networking by topic
Case studies
Small group discussions
Action plans
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