[Federal Register Volume 74, Number 172 (Tuesday, September 8, 2009)]
[Notices]
[Pages 46214-46215]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: E9-21546]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2009-N-0664]


2009 Parenteral Drug Association and Food and Drug Administration 
Joint Regulatory Conference

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice of meeting.

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SUMMARY: The Food and Drug Administration (FDA) in co-sponsorship with 
the Parenteral Drug Association (PDA), is announcing a conference 
entitled ``Securing the Future of Medical Product Quality: A 2020 
Vision.'' The workshop helps to achieve objectives set forth in the FDA 
Modernization Act of 1997, which include working closely with 
stakeholders and maximizing the availability and clarity of information 
to stakeholders and the public.
    Date and Time: The conference will be held on Monday, September 14, 
2009 from 8 a.m. to 6 p.m.; Tuesday, September 15, 2009 from 7:15 a.m. 
to 5:45 p.m.; and Wednesday, September 16 from 7:15 a.m. to 1:15 p.m.
    Location: The public workshop will be held at the Renaissance 
Hotel, 999 9th St., Washington, D.C., 20001; 1-202-898-9000; FAX: 1-
202-289-0947.
    Contact: Regarding the conference: Wanda Neal, Parenteral Drug 
Association, PDA Global Headquarters, Bethesda Towers, 4350 East-West 
Hwy., suite 200, Bethesda, MD 20814.
    Regarding this document: Ken Nolan, Office of External Relations, 
Food and Drug Administration, 5600 Fishers Lane, rm. 15-05, Rockville, 
MD 20857, 301-827-3376.
    Registration: You are encouraged to register at your earliest 
convenience. The PDA registration fees cover the cost of facilities, 
materials, and breaks. Seats are limited; please submit your 
registration as soon as possible. Conference space will be filled in 
order of receipt of registration. Those accepted in to the conference 
will receive confirmation. Registration will close after applicable 
conference is filled. Onsite registration will be available on a space-
available basis on the day of the public conference, beginning at 7 
a.m. on Monday, September 14, 2009.
    The cost of registration is as follows:

PDA Members........................  $1850.00
PDA Non-members....................  $2099.00
Government.........................  $700.00
PDA Member Academic/Health           $700.00
 Authority.

[[Page 46215]]

 
PDA Non-Member Academic/Health       $875.00
 Authority.
PDA Member Students................  $200.00
Non-Member Students................  $310.00
 

    If you need special accommodations due to a disability, please 
contact Wanda Neal, PDA (see Contact), at least 7 days in advance of 
the workshop.
    Registration instructions: To register, please submit your name, 
affiliation, mailing address, phone, fax number, and e-mail, along with 
a check or money order payable to ``PDA.'' Mail to: PDA, Global 
Headquarters, Bethesda Towers, 4350 East-West Hwy., suite 200, 
Bethesda, MD 20814. To register via the Internet, go to the PDA Web 
site at http://www.pda.org. (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).
    The registrar will also accept payment by major credit cards (VISA/
MasterCard only). For more information on the meeting, or for questions 
on registration, contact the Parenteral Drug Association (PDA), 301-
656-5900, FAX: 301-986-1093, or e-mail: <a href="/cdn-cgi/l/email-protection#5a33343c351a2a3e3b7435283d"><span class="__cf_email__" data-cfemail="b2dbdcd4ddf2c2d6d39cddc0d5">[email protected]</span></a>.
    Attendees are responsible for their own accommodations. To make 
reservations at the Renaissance Hotel at the reduced conference rate, 
contact the Renaissance Hotel (see Location), citing meeting code 
``PDA.'' Room rates are: Single: $274, plus 14.5% state and local 
taxes; and Double: $274, plus 14.5% state and local taxes. Reservations 
can be made on a space and rate availability basis.

SUPPLEMENTARY INFORMATION:  The PDA/FDA Joint Regulatory Conference 
offers the unique opportunity to join FDA representatives and industry 
experts in face-to-face dialogues. Each year, FDA speakers provide 
updates on the current state of efforts impacting the development of 
global regulatory strategies, while industry professionals from some of 
today's leading pharmaceutical companies present case studies on how 
they employ global strategies in their daily processes. Participants 
will hear directly from FDA experts and representatives of global 
regulatory authorities and take home best practices for compliance. The 
conference will span 2 1[sol]2 days and cover current issues affecting 
the industry, including the following issues:
    <bullet> Pharmaceutical safety and good manufacturing practices,
    <bullet> Continual improvement,
    <bullet> Technology transfer,
    <bullet> Supply chain,
    <bullet> Combination products,
    <bullet> Recall root causes,
    <bullet> Knowledge management,
    <bullet> Good distribution practices and good importer practices, 
and
    <bullet> Process validation and quality risk management.
The conference program will include PDA Interest Group sessions as well 
as an exhibition on September 14 and 15.
    Immediately following the conference, on September 17 and 18, the 
PDA Training and Research Institute (PDA TRI) is offering courses to 
complement conference sessions.
    FDA has made continuing education of the biologics, drug, and 
device manufacturing community a high priority to help ensure the 
quality of FDA-regulated pharmaceuticals and devices. The workshop 
helps to achieve objectives set forth in section 406 of the FDA 
Modernization Act of 1997 (21 U.S.C. 393), which include working 
closely with stakeholders and maximizing the availability and clarity 
of information to stakeholders and the public. The workshop also is 
consistent with the Small Business Regulatory Enforcement Fairness Act 
of 1996 (Public Law 104-121), as outreach activities by Government 
agencies to small businesses.

    Dated: September 1, 2009.
David Horowitz,
Assistant Commissioner for Policy.
[FR Doc. E9-21546 Filed 9-4-09; 8:45 am]
BILLING CODE 4160-01-S


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