[Federal Register Volume 80, Number 48 (Thursday, March 12, 2015)]
[Notices]
[Pages 13008-13009]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2015-05513]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2015-N-0001]


2015 Parenteral Drug Association/Food and Drug Administration 
Joint Conference

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice of public conference.

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    The Food and Drug Administration (FDA), is announcing a public 
conference, to be held in co-sponsorship with the Parenteral Drug 
Association (PDA), entitled ``Mission Possible: Patient-Focused 
Manufacturing, Quality, and Regulatory Solutions.'' The conference will 
cover current issues affecting the industry as well as explore 
strategies 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 28, 
2015, from 7 a.m. to 7:30 p.m.; September 29, 2015, from 7 a.m. to 9:30 
p.m.; and September 30, 2015, from 7 a.m. to 12:30 p.m.
    Location: The public conference will be held at the Renaissance 
Washington Hotel, 999 Ninth Street 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 150, 
Bethesda, MD 20814, 301-656-5900, ext. 111, FAX: 301-986-1093, email: 
<a href="/cdn-cgi/l/email-protection#40292e262f003024216e2f3227"><span class="__cf_email__" data-cfemail="fd94939b92bd8d999cd3928f9a">[email protected]</span></a>; or Ken Nolan, Office of Communications, Food and Drug 
Administration, 10903 New Hampshire Ave., Silver Spring, MD 20993, 301-
796-8629, email: <a href="/cdn-cgi/l/email-protection#1c77797272796874327273707d725c7a787d3274746f327b736a"><span class="__cf_email__" data-cfemail="b0dbd5deded5c4d89ededfdcd1def0d6d4d19ed8d8c39ed7dfc6">[email protected]</span></a>.
    Accommodations: Attendees are responsible for their own 
accommodations. To make reservations, contact the Renaissance 
Washington Hotel (see Location) and reference ``the 2015 PDA/FDA Joint 
Regulatory Conference'' to receive the PDA group rate. Room rates are: 
Single: $305 plus 14.5 percent State and local taxes. Requests will be 
processed on a first-come, first-served 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 beginning at 1 p.m. on September 27, 2015, and at 7 
a.m. from September 28 through 30, 2015. The cost of registration is as 
follows:

                          Cost of Registration
------------------------------------------------------------------------
                                                  July 19-      After
           Affiliation             Before July   August 18,   August 18,
                                     19, 2015       2015         2015
------------------------------------------------------------------------
     Premier Package (Includes Conference and Workshop Registration)
------------------------------------------------------------------------
Member...........................       $3,240       $3,490       $3,740
Nonmember........................        3,599        3,849        4,099
------------------------------------------------------------------------
                             Conference Only
------------------------------------------------------------------------
Member...........................        1,895        2,095        2,295
Nonmember........................        2,154        2,354        2,554
Government/Health Authority                700          700          700
 Member..........................
Government/Health Authority                800          800          800
 Nonmember *.....................
Academic Member..................          700          700          700
Academic Nonmember *.............          800          800          800

[[Page 13009]]

 
Student Member...................          280          280          280
Student Nonmember *..............          310          310          310
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* For this member type, online registration is not available and must be
  faxed in.

    Please visit PDA's Web site: www.pda.org/pdafda2015 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 150, 
Bethesda, MD 20814. To register via the Internet, go to PDA's Web site: 
www.pda.org/pdafda2015.
    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 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:
    <bullet> Product Quality
    <bullet> Data Integrity
    <bullet> Breakthrough Therapies
    <bullet> Regulatory Challenges and Opportunities
    <bullet> Lifecycle Management
    <bullet> Clinically Relevant Specifications
    <bullet> Food and Drug Administration Safety and Innovation Act
    <bullet> Quality Metrics/Quality Culture
    <bullet> Manufacturing of the Future With Submissions
    <bullet> Continuous Verification and Validation
    <bullet> Continuous Manufacturing
    <bullet> ``Fishbowl'' Role Play
    <bullet> Quality Systems
    <bullet> Contract Manufacturing Organizations
    <bullet> Maturity of Quality Systems
    <bullet> Investigations
    <bullet> Case Studies for Quality
    <bullet> Quality Submissions
    <bullet> Prescription Drug User Fee Act
    <bullet> Risk-Based Control Strategies
    <bullet> Supply Chain
    <bullet> Quality Risk Management Systems
    <bullet> Drug Shortages
    <bullet> Customer Complaint Reviews and Trending
    <bullet> Human Factors
    <bullet> Office of Pharmaceutical Quality and Program Alignment 
Group
    <bullet> Patient Perspective
    <bullet> Compliance Update
    <bullet> Center Initiatives--Regulatory Submission Update
    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: March 4, 2015.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2015-05513 Filed 3-11-15; 8:45 am]
 BILLING CODE 4164-01-P


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