[Federal Register Volume 78, Number 65 (Thursday, April 4, 2013)]
[Notices]
[Pages 20325-20326]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2013-07854]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2013-N-0001]


2013 Parenteral Drug Association/Food and Drug Administration 
Joint Regulatory Conference: Driving Quality and Compliance Throughout 
the Product Life Cycle in a Global Regulatory Environment

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice of public conference.

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    The Food and Drug Administration (FDA), in co-sponsorship with the 
Parenteral Drug Association (PDA), is announcing a public conference 
titled ``Driving Quality and Compliance Throughout the Product Life 
Cycle in a Global Regulatory Environment.'' 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 16, 
2013, from 7 a.m. to 6 p.m.; September 17, 2013, from 7:30 a.m. to 6:15 
p.m.; and September 18, 2013, from 7:30 a.m. to 12:15 p.m.
    Location: The public conference will be held at the Renaissance 
Washington Hotel, 999 9th St. NW., Washington, DC 20001, 202-898-9000, 
FAX: 202-289-0947.
    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] or Ken Nolan, Office of the Commissioner, Food and Drug 
Administration, 10903 New Hampshire Ave., Bldg. 32, rm. 5314, Silver 
Spring, MD 20993, 301-796-8629, email: [email protected].
    Accommodations: Attendees are responsible for their own 
accommodations. To make reservations at the Renaissance Washington 
Hotel at the reduced conference rate, contact the Renaissance 
Washington Hotel (see Location)--cite the meeting code ``PDA.'' Room 
rates are: Single or Double: $299, plus 14.5 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 16, 2013. The cost of registration is as follows:

[[Page 20326]]



                          Cost of Registration
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                                       Through  August  After  August 6,
             Affiliation                   6, 2013            2013
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Member..............................            $1,895            $2,095
Nonmember...........................             2,144             2,344
Government/Health Authority Member..               700               700
Government/Health Authority                        800               800
 Nonmember *........................
Academic Member.....................               700               700
Academic Nonmember *................               800               800
Student Member......................               280               280
Student Nonmember *.................               310               310
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* Applicable Nonmember rates.

    Please visit PDA's Web site at  http://www.pda.org/pdafda2013 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 your 
registration information along with your payment 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 
at http://www.pda.org/pdafda2013.
    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: Please be advised that 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: April 1, 2013.
Peter Lurie,
Acting Associate Commissioner for Policy and Planning.
[FR Doc. 2013-07854 Filed 4-3-13; 8:45 am]
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