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2008 PDA/FDA JOINT REGULATORY CONFERENCE
DATE: September 8-10, 2008
LOCATION: Renaissance Hotel, 999 9th Street NW, Washington, D.C. 20001
CONTACT: Leslie Edmonds, Coordinator, Programs and Meetings, edmonds@pda.org or (301) 656-5900 ext. 160. In the years that have passed since FDA announced the Good Manufacturing Practices (GMPs) for the 21st Century initiative, regulatory health authorities and industry have partnered by harmonizing requirements and implementing new systems for assuring and maintaining pharmaceutical quality. The 2008 PDA/FDA Joint Regulatory Conference will provide examples of how these new approaches have been successfully implemented. In addition, the conference will examine what is working well and where the industry and regulatory health authorities still need to work to achieve modernized quality systems. More Information
FDA NANOTECHNOLOGY PUBLIC MEETING
DATE: September 8, 2008, 8:30 a.m.
LOCATION: University Systems of Maryland,
The Universities at Shady Grove Conference Center,
9630 Gudelsky Drive,
Rockville, MD
CONTACT: Email nanotech@fda.hhs.gov or call 301-827-3360. The Food and Drug Administration (FDA) is announcing a public meeting to gather information that will assist the Agency in implementing the recommendations of the Nanotechnology Task Force Report. More Information
REPRODUCTIVE HEALTH DRUGS ADVISORY COMMITTEE
DATE: September 9, 2008, 8:00 a.m.
LOCATION: Hilton Washington DC Rockville,
Plaza Ballrooms I and II,
1750 Rockville Pike,
Rockville, MD
CONTACT: Kalyani Bhatt, 301–827–7001. The committee will discuss new drug application (NDA) 22–242, proposed trade name FABLYN (lasofoxifene tartrate) Tablets, 0.5 milligrams (mg), Pfizer Inc., for the proposed indication of the treatment of osteoporosis in postmenopausal women at increased risk of fracture. More Information
BLOOD PRODUCTS ADVISORY COMMITTEE
DATE: September 10-11, 8:00 a.m.
LOCATION: Hilton Hotel, Washington, DC/Rockville Executive Meeting Center, 1750 Rockville Pike, Rockville, MD 20852
CONTACT: Donald W. Jehn or Pearline K. Muckelvene, 301-827-0314. On the morning of September 10, 2008, the Committee will hear an update on the May 29 to 30, 2008, meeting of the Department of Health and Human Services Advisory Committee on Blood Safety and Availability. Following this update, the Committee will discuss strategies to enhance bacterial safety of 7 day platelets for transfusion. In the afternoon, the Committee will discuss iron status in blood donors. On September 11, 2008, the Committee will hear updates on the following topics: (1) April 29 to 30, 2008, workshop on hemoglobin based oxygen carriers; (2) July 10 to 11, 2008, blood establishment computer software conference; (3) the development of an automated Biologics License Application submission system; and (4) Draft Guidance for Industry: Re- qualification Method for Re-entry of Blood Donors Deferred Because of Reactive Test Results for Antibody to Hepatitis B Core Antigen (Anti- HBc). Following these updates, the Committee will discuss options for blood donor screening and re-entry for malaria. More Information
PDA/FDA PHARMACEUTICAL INGREDIENT SUPPLY CHAIN CONFERENCE
DATE: September 10-12, 2008
LOCATION: Liaison Capitol Hill, 415 New Jersey Avenue, NW, Washington, D.C. 20001
CONTACT: Meaghan Dowd, Senior Programs Coordinator, dowd@pda.org or (301) 656-5900 ext. 136. Join regulatory and industry representatives from some of today’s leading organizations at the PDA/FDA Pharmaceutical Ingredient Supply Chain Conference to learn about the development of global initiatives to ensure the integrity of the Pharmaceutical Supply Chain. Theconference will provide information regarding guidance and regulations from various regions, including North America, Europe and Asia, as the industry moves towards global cooperation and harmonization of Good Distribution Practices (GDPs) and controls pertaining to the Ingredient Supply Chain. This meeting will immediately follow the 2008 PDA/FDA Joint Regulatory Conference. More Information.
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