[Federal Register Volume 77, Number 152 (Tuesday, August 7, 2012)]
[Notices]
[Pages 47078-47079]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2012-19295]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2012-N-0001]


2012 Parenteral Drug Association/Food and Drug Administration 
Joint Regulatory Conference; Compliance Through Quality Systems: 
Implementing and Advancing a Sustainable Global Quality Culture

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice of public conference.

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SUMMARY: The Food and Drug Administration (FDA), in cosponsorship with 
Parenteral Drug Association (PDA), is announcing a public conference 
entitled ``Compliance Through Quality Systems: Implementing and 
Advancing a Sustainable Global Quality Culture.'' The conference will 
cover current issues affecting the industry as well as explore 
strategies and approaches for ensuring conformance with regulations to 
facilitate the development and continuous improvement of safe and 
effective medical products. The conference establishes a unique forum 
to discuss the foundations, emerging technologies and innovations in 
regulatory science, as well as the current quality and compliance areas 
of concerns. Meeting participants will hear from FDA and industry 
speakers about the requirements and best practices to consider while 
implementing robust quality systems in order to deliver the best 
quality product.
    Date and Time: The public conference will be held on September 10, 
2012, from 7 a.m. to 6 p.m.; September 11, 2012, from 7:30 a.m. to 6:15 
p.m.; and September 12, 2012, from 7:30 a.m. to 12:15 p.m.
    Location: The public conference will be held at the Baltimore 
Marriott Waterfront Hotel, 700 Aliceanna St., Baltimore, MD 21202, 410-
385-3000, Fax: 410-895-1900.
    Contact: Wanda Neal, Parenteral Drug Association, PDA Global 
Headquarters, Bethesda Towers, 4350 East West Hwy., Suite 200, 
Bethesda, MD 20814, 301-656-5900, ext. 111, Fax: 301-986-1093, email: 
[email protected].
    Accommodations: Attendees are responsible for their own 
accommodations. To make reservations at the Baltimore Marriott 
Waterfront Hotel at the reduced conference rate, contact the Baltimore 
Marriott Waterfront Hotel (see Location)--cite the meeting code 
``PDA.'' Room rates are: Single: $229, plus 15.5 percent state and 
local taxes and Double: $229, plus 15.5 percent state and local taxes. 
Reservations can be made on a space and rate availability basis.
    Registration: Attendees are encouraged to register at their 
earliest convenience. The PDA registration fees cover the cost of 
facilities, materials, and refreshments. Seats are limited; please 
submit your registration as soon as possible. Conference space will be 
filled in order of receipt of registration. Those accepted for the 
conference will receive confirmation. Registration will close after the 
conference is filled. Onsite registration will be available on a space 
available basis on each day of the public conference beginning at 7 
a.m. on September 10, 2012. The cost of registration is as follows:

                      Table 1--Cost of Registration
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                                     Through  August   After  August 10,
            Affiliation                  10, 2012             2012
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Member............................             $1,700             $1,900
Nonmember.........................              1,949              2,149
Government/Health Authority Member                530                530
Government/Health Authority                       700                700
 Nonmember \1\....................
Academic Member...................                700                700
Academic Nonmember \1\............                800                800
Student Member....................                280                280

[[Page 47079]]

 
Student Nonmember \1\.............                310                310
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\1\ Applicable nonmember rates.

    Please visit PDA's Web site: http://www.pda.org/pdafda2012 to 
confirm the prevailing registration fees. (FDA has verified the Web 
site address, but FDA is not responsible for any subsequent changes to 
the Web site after this document publishes in the Federal Register.)
    If you need special accommodations due to a disability, please 
contact Wanda Neal (see Contact), at least 7 days in advance of the 
conference.
    Registration Instructions: To register, please submit your name, 
affiliation, mailing address, telephone, fax number, and email address, 
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 PDA's Web site: 
http://www.pda.org/pdafda2012.
    The registrar will also accept payment by major credit cards (VISA/
American Express/MasterCard only). For more information on the meeting, 
or for questions on registration, contact PDA (see Contact).
    Transcripts: As soon as a transcript is available, it can be 
obtained in either hardcopy or on CD-ROM, after submission of a Freedom 
of Information request. Written requests are to be sent to Division of 
Freedom of Information (ELEM-1029), Food and Drug Administration, 12420 
Parklawn Dr., Element Bldg., Rockville, MD 20857.

SUPPLEMENTARY INFORMATION: The PDA/FDA Joint Regulatory Conference 
offers the unique opportunity for participants to join FDA 
representatives and industry experts in face-to-face dialogues. Each 
year, FDA speakers provide updates on current efforts affecting 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.
    Through a series of sessions and meetings, the conference will 
provide participants with the opportunity to hear directly from FDA 
experts and representatives of global regulatory authorities on best 
practices, including:
     Regulatory Submission and Meetings
     Quality Risk Management Implementation
     Manufacturing in the Future
     Quality Systems
     Regulatory Considerations During Development
     Cell Therapy Innovations
     Life Cycle Management
     Process Validation
     Validation FDA Guidance
     Challenges of Contract Manufacturing Organizations
     Contract Agreements
     Drug Safety
     Emerging Active Pharmaceutical Ingredients (API) 
Regulations
     Investigations
     Emerging API Regulations
     User Fees
     Excipient Best Practices
     Good Manufacturing Practices Foreign Inspections Findings
     Regulatory Process to Approval (Inspectional Readiness)
     Combination Products and Companion Diagnostics
    To help ensure the quality of FDA-regulated products, the workshop 
helps to achieve objectives set forth in section 406 of the FDA 
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 workshop also is 
consistent with the Small Business Regulatory Enforcement Fairness Act 
of 1996 (Pub. L. 104-121), as outreach activities by Government 
Agencies to small businesses.

    Dated: August 1, 2012.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2012-19295 Filed 8-6-12; 8:45 am]
BILLING CODE 4160-01-P