2010-7151. Pharmaceutical Supply Chain; Public Workshop

AGENCY:

Food and Drug Administration, HHS.

ACTION:

Notice of public workshop.

SUMMARY:

The Food and Drug Administration (FDA) is announcing a public workshop entitled “2010 PDA/FDA Pharmaceutical Supply Chain Workshop—Enough Talk: Let's Find and Implement Solutions.” The workshop, cosponsored with the Parenteral Drug Association (PDA), will focus on solutions to reduce the risk to product quality in the pharmaceutical supply chain.

Date and Time: The conference will be held on Monday, April 26, 2010, from 8 a.m. to 6 p.m.; Tuesday, April 27, 2010, from 7:15 a.m. to 5:45 p.m.; and Wednesday, April 28, 2010, from 7:15 a.m. to 1:15 p.m.

Location: The public workshop will be held at the Hyatt Regency Bethesda, 7400 Wisconsin Ave., 1 Bethesda Metro Center, Bethesda, MD 20814; Phone: [phone]; FAX: [phone].

Contact: Wanda Neal, Parenteral Drug Association, PDA Global Headquarters, Bethesda Towers, 4350 East-West Hwy., Suite 200, Bethesda, MD 20814; Phone: [phone], ext. 149.

Accommodations: Attendees are responsible for their own accommodations. To make reservations at the Hyatt Regency Bethesda, at the reduced conference rate, contact the Hyatt Regency Bethesda (see Location), citing meeting code “PDA.” Room Rates are: Single: $209, plus 13% state and local taxes and Double: $234, plus 13% state and local taxes. Reservations can be made on a space and rate availability basis.

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, April 26, 2010.

The cost of registration is as follows:

PDA Members	$1850
PDA Nonmembers	$2099
PDA Member Government	$530
PDA Nonmember Government	$530
PDA Member Health Authority	$700
PDA Nonmember Health Authority	$800
PDA Member Academic	$700
PDA Nonmember Academic	$780
PDA Member Students	$280
PDA Nonmember Students	$310

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 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 Internet, go to See PDA Web site, www.pda.org/​supplychain2010 (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 PDA: Phone: [phone], FAX: [phone], or e-mail: [e-mail].

SUPPLEMENTARY INFORMATION:

A reliable supply of high quality, safe, and effective drug products and drug ingredients depends upon a series of controls across the entire supply chain from sourcing of incoming starting materials to distribution controls to marketing. Recent experiences in the market have highlighted the need for effective controls across the supply chain. There is a surge in global cooperation and efforts toward harmonization of good manufacturing practices (GMPs) and good distribution practices (GDPs) and controls pertaining to the supply chain among members of industry and regulatory agencies. Understanding and securing the entire ingredient manufacturing and distribution chain helps to ensure the quality and safety of medicines for patients.

Through a series of plenary sessions and working group breakout sessions, the workshop will provide participants the opportunity to:

• Hear from senior FDA personnel on the current regulatory environment.
• Share improvements in programs and technology.
• Identify any barriers to securing the entire ingredient manufacturing and distribution chain and associated actions to implement effective solutions.

Personnel with experience related to supply chain issues, including quality and technical functions, will find this level of information exchange with members of industry and regulatory agencies useful to their specific areas.

Dated: March 25, 2010.

Leslie Kux,

Acting Assistant Commissioner for Policy.