 |
 |
 |
|
 |
FDA Home Page | Search
FDA Site | FDA A-Z Index | Contact
FDA | FDA Centennial
Participants in the workshop on Good Manufacturing Practices sponsored by the HHS Food and Drug Administration in May 2007; those who attended included regulators from countries that have experienced, or are at risk of experiencing, an outbreak of highly pathogenic avian influenza. |
The U.S. Food and Drug Administration (FDA) sponsored a Good Manufacturing Practice (GMP) Workshop for regulators from countries at risk of experiencing an avian / pandemic influenza. Invited participants were from the medical products regulatory agencies of Argentina, Brazil, Chile, Egypt, Hong Kong SAR, India, Indonesia, Jordan, Mexico, Nigeria, Philippines, Russia, Thailand, Tunisia, & Vietnam. Participating faculty were from Australia, and WHO.
The Workshop provided a unique opportunity for countries engaged in pandemic influenza preparedness planning activities to benefit from capacity building in the field of human drugs and vaccine GMPs. The 4-day exchange of information among the 28 invitees, our contributing regulatory counterparts, and US FDA experts in GMP regulatory review, compliance, and inspections offered insight and instruction to enhance the safety and quality of manufacturing of pharmaceuticals and vaccines.
The highlight of the meeting was an unscheduled visit from the Commissioner of FDA. Dr. Andrew C. von Eschenbach remarks included praising the Workshop participants for their vision in understanding the critical importance of GMPs as a means for ensuring safe and quality products that protect and enhance the public health around the world.
The FDA´s Office of International Programs was responsible for bringing together antiviral drug, and vaccine manufacturing experts from the Center for Drug Evaluation and Research, the Center for Biologic Evaluation and Research, and the Office of Regulatory Affairs for this intra agency training held May 15-18, 2007 in Rockville, Maryland.
This Workshop is part of an overall strategy for pandemic influenza planning and preparedness, recognizing the global nature of public health issues, and the need to work with foreign counterpart regulatory agencies and international organizations in carrying out our mission.
