[Federal Register Volume 76, Number 158 (Tuesday, August 16, 2011)]
[Notices]
[Pages 50741-50742]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2011-20791]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2011-N-0002]
2011 Parenteral Drug Association/Food and Drug Administration
Joint Public Conference; Quality and Compliance in Today's Regulatory
Enforcement Environment
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice of public conference.
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The Food and Drug Administration (FDA), in cosponsorship with
Parenteral Drug Association (PDA), is announcing a public conference
entitled ``Quality and Compliance in Today's Regulatory Enforcement
Environment.'' The conference will span 2\1/2\ days and 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 19,
2011, from 7 a.m. to 6 p.m.; September 20, 2011, from 7:30 a.m. to 6:15
p.m.; and September 21, 2011, from 7:30 a.m. to 12:15 p.m.
Location: The public conference will be held at the Renaissance
Hotel, 999 Ninth 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, FAX: 301-986-1093, e-mail:
[email protected].
Accommodations: 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)--
cite the meeting code ``PDA.'' Room rates are: Single: $288, plus 14.5%
state and local taxes and Double: $288, 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 19, 2011. The cost of registration is as follows:
Cost of Registration
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Affiliation Fee
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PDA Members.................................................. $1,895
NonMembers................................................... 2,144
PDA Member Government/Health Authority....................... 700
NonMember Government/Health Authority........................ 800
PDA Member Academic.......................................... 700
NonMember Academic........................................... 780
PDA Member Students.......................................... 280
NonMember Students........................................... 310
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Please visit PDA's Web site: http://www.pda.org/pdafda2011 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 e-mail
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
[[Page 50742]]
Internet, go to PDA's Web site: http://www.pda.org/pdafda2011.
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 public 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:
Accountability in a Global Environment--Enforcement and
Supply Chain
Office of International Programs 101 & Foreign Inspections
International Conference on Harmonization Q11
New Regulations--Status Update
First Cycle Review
Drug Safety
Good Inspection Practices--Domestic
Process Validation
Emerging Regulations for Positron Emission Tomography
FDA/Pharmaceutical Inspection Co-operation Scheme
Standards
International Compliance Update
Good Manufacturing Practice Life Cycle
Supply Chain
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 11, 2011.
Leslie Kux,
Acting Assistant Commissioner for Policy.
[FR Doc. 2011-20791 Filed 8-15-11; 8:45 am]
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