Document ID: FDA-2016-N-0001-0008
Agency: fda
Document Type: Notice
Title: Food and Drug Administration/Xavier University PharmaLink Conference:
Increasing Product Confidence
Posted Date: 2016-01-26T05:00Z

[Federal Register Volume 81, Number 16 (Tuesday, January 26, 2016)]
[Notices]
[Pages 4311-4312]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2016-01486]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2016-N-0001]

Food and Drug Administration/Xavier University PharmaLink 
Conference: Increasing Product Confidence

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

[[Page 4312]]

University, is announcing a public conference entitled ``FDA/Xavier 
University PharmaLink Conference: Increasing Product Confidence''. The 
PharmaLink conference seeks solutions to important and complicated 
issues by aligning with the strategic priorities of FDA, featuring 
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 
dialogue, which has led to innovative initiatives.

DATES: The public conference will be held on March 16, 2016, from 8:30 
a.m. to 5 p.m.; March 17, 2016, from 8:30 a.m. to 5p.m.; and March 18, 
2016, from 8:30 a.m. to 12:20 p.m.

ADDRESSES: The public conference will be held on the campus of Xavier 
University, 3800 Victory Pkwy., Cincinnati, OH 45207; 513-745-3016.

FOR FURTHER INFORMATION CONTACT: For information regarding this 
document: Steven Eastham, Food and Drug Administration, Cincinnati 
South Office, 36 East 7th St., Cincinnati, OH 45202; 513-246-4134, 
steven.eastham@fda.hhs.gov.
    For information regarding the conference and registration: Mason 
Rick, Xavier University, 3800 Victory Pkwy., Cincinnati, OH 45207-5471; 
513-745-3016, rickm@xavier.edu.

SUPPLEMENTARY INFORMATION:

I. Background

    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.

II. Meeting Information

A. Registration

    There is a registration fee. The conference registration fees cover 
the cost of the presentations, training materials, receptions, 
breakfasts and lunches for the 2.5 days of the conference. There will 
be onsite registration. The cost of registration is as follows:

                     Table 1--Registration Fees \1\
------------------------------------------------------------------------
                                                                Standard
                        Attendee type                             rate
------------------------------------------------------------------------
Industry.....................................................     $1,895
Small Business (<100 employees)..............................      1,295
Supplier.....................................................        600
Start-up 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 number, email address, and payment information 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 headquarters 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.
    If you need special accommodations due to a disability, please 
contact Mason Rick (see FOR FURTHER INFORMATION CONTACT) at least 7 
days in advance of the conference.

B. Purpose and Scope of Meeting

    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:
     Office of Compliance Update
     Data Integrity
     Medicines and Healthcare products Regulatory Agency (MHRA) 
Update: Strategic Priorities and Initiatives
     Operating in India and Southeast Asia
     Serialization
     Integrity of Supply
     Office of Pharmaceutical Quality Update
     How to Measure Quality Culture
     Pharmaceutical Metrics and the Value Proposition
     Office of Regulatory Affairs Update
     The 21st Century Cures Act: Goals and Impact
     International Conference on Harmonisation Q12: Technical 
and Regulatory Considerations for Pharmaceutical Product Lifecycle 
Management
     Barriers to Quality and Supply Chain Excellence
     Proactive and Systematic Quality Implementation: Case 
Studies across functional areas
     FDA and MHRA Investigator Insights
    The conference includes:
     Networking by topic
     Case Studies
     Small Group Discussions
     Action Plans
     Keynote dinner at Paul Brown Stadium (Home of the 
Cincinnati Bengals)
    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, 2016.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2016-01486 Filed 1-25-16; 8:45 am]
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