[Federal Register Volume 79, Number 32 (Tuesday, February 18, 2014)]
[Notices]
[Page 9229]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2014-03454]
-----------------------------------------------------------------------
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.
-----------------------------------------------------------------------
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: [email protected].
For information regarding the conference and registration: Marla
Phillips, Xavier University, 3800 Victory Pkwy., Cincinnati, OH 45207,
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:
Table1.--Registration Fees \1\
------------------------------------------------------------------------
Registration
Attendee type fees
------------------------------------------------------------------------
Industry................................................ $1,895
Small Business (<100 employees)......................... $1,295
Startup Manufacturer.................................... $300
Academic................................................ $300
Media................................................... Free
Government.............................................. 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: 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