[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]
-----------------------------------------------------------------------
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.
-----------------------------------------------------------------------
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:
[email protected]; or Ken Nolan, Office of Communications, Food and Drug
Administration, 10903 New Hampshire Ave., Silver Spring, MD 20993, 301-
796-8629, email: [email protected].
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
------------------------------------------------------------------------
* 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:
Product Quality
Data Integrity
Breakthrough Therapies
Regulatory Challenges and Opportunities
Lifecycle Management
Clinically Relevant Specifications
Food and Drug Administration Safety and Innovation Act
Quality Metrics/Quality Culture
Manufacturing of the Future With Submissions
Continuous Verification and Validation
Continuous Manufacturing
``Fishbowl'' Role Play
Quality Systems
Contract Manufacturing Organizations
Maturity of Quality Systems
Investigations
Case Studies for Quality
Quality Submissions
Prescription Drug User Fee Act
Risk-Based Control Strategies
Supply Chain
Quality Risk Management Systems
Drug Shortages
Customer Complaint Reviews and Trending
Human Factors
Office of Pharmaceutical Quality and Program Alignment
Group
Patient Perspective
Compliance Update
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