E9-21546. 2009 Parenteral Drug Association and Food and Drug Administration Joint Regulatory Conference

AGENCY:

Food and Drug Administration, HHS.

ACTION:

Notice of meeting.

SUMMARY:

The Food and Drug Administration (FDA) in co-sponsorship with the Parenteral Drug Association (PDA), is announcing a conference entitled “Securing the Future of Medical Product Quality: A 2020 Vision.” The workshop helps to achieve objectives set forth in the FDA Modernization Act of 1997, which include working closely with stakeholders and maximizing the availability and clarity of information to stakeholders and the public.

Date and Time: The conference will be held on Monday, September 14, 2009 from 8 a.m. to 6 p.m.; Tuesday, September 15, 2009 from 7:15 a.m. to 5:45 p.m.; and Wednesday, September 16 from 7:15 a.m. to 1:15 p.m.

Location: The public workshop will be held at the Renaissance Hotel, 999 9th St., Washington, D.C., 20001; 1-202-898-9000; FAX: [phone].

Contact: Regarding the conference: Wanda Neal, Parenteral Drug Association, PDA Global Headquarters, Bethesda Towers, 4350 East-West Hwy., suite 200, Bethesda, MD 20814.

Regarding this document: Ken Nolan, Office of External Relations, Food and Drug Administration, 5600 Fishers Lane, rm. 15-05, Rockville, MD 20857, 301-827-3376.

Registration: You are encouraged to register at your earliest convenience. The PDA registration fees cover the cost of facilities, materials, and breaks. Seats are limited; please submit your registration as soon as possible. Conference space will be filled in order of receipt of registration. Those accepted in to the conference will receive confirmation. Registration will close after applicable conference is filled. Onsite registration will be available on a space-available basis on the day of the public conference, beginning at 7 a.m. on Monday, September 14, 2009.

The cost of registration is as follows:

PDA Members	$1850.00
PDA Non-members	$2099.00
Government	$700.00
PDA Member Academic/Health Authority	$700.00
PDA Non-Member Academic/Health Authority	$875.00
PDA Member Students	$200.00
Non-Member Students	$310.00

If you need special accommodations due to a disability, please contact Wanda Neal, PDA (see Contact), at least 7 days in advance of the workshop.

Registration instructions: To register, please submit your name, affiliation, mailing address, phone, fax number, and e-mail, 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 the PDA Web site at http://www.pda.org. (FDA has verified the Web site address, but is not responsible for subsequent changes to the Web site after this document publishes in the Federal Register).

The registrar will also accept payment by major credit cards (VISA/MasterCard only). For more information on the meeting, or for questions on registration, contact the Parenteral Drug Association (PDA), 301-656-5900, FAX: [phone], or e-mail: [e-mail].

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), citing meeting code “PDA.” Room rates are: Single: $274, plus 14.5% state and local taxes; and Double: $274, plus 14.5% state and local taxes. Reservations can be made on a space and rate availability basis.

SUPPLEMENTARY INFORMATION:

The PDA/FDA Joint Regulatory Conference offers the unique opportunity to join FDA representatives and industry experts in face-to-face dialogues. Each year, FDA speakers provide updates on the current state of efforts impacting 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. Participants will hear directly from FDA experts and representatives of global regulatory authorities and take home best practices for compliance. The conference will span 2 1/2 days and cover current issues affecting the industry, including the following issues:

• Pharmaceutical safety and good manufacturing practices,
• Continual improvement,
• Technology transfer,
• Supply chain,
• Combination products,
• Recall root causes,
• Knowledge management,
• Good distribution practices and good importer practices, and
• Process validation and quality risk management.

The conference program will include PDA Interest Group sessions as well as an exhibition on September 14 and 15.

Immediately following the conference, on September 17 and 18, the PDA Training and Research Institute (PDA TRI) is offering courses to complement conference sessions.

FDA has made continuing education of the biologics, drug, and device manufacturing community a high priority to help ensure the quality of FDA-regulated pharmaceuticals and devices. The workshop helps to achieve objectives set forth in section 406 of the FDA Modernization Act of 1997 (21 U.S.C. 393), which include 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 (Public Law 104-121), as outreach activities by Government agencies to small businesses.

Dated: September 1, 2009.

David Horowitz,

Assistant Commissioner for Policy.