PQRI Workshop to Address Blend Uniformity

ARLINGTON, Va. — The ProductQuality Research Institute (PQRI) Workshop on Blend Uniformity will takeplace Sept. 7-8, 2000 at the Crystal Gateway Marriott in Arlington, Va.The objective of the workshop is to encourage an open dialogue among industry,academia, the government and the public on blend uniformity.

"The fact that the FDA has waited until after this workshop to issue its final rule on blend uniformity speaks to the importance that FDA places on PQRI," said Tobias Massa, Ph.D., member of PQRI’s Board of Directors and chair of the PQRI Scientific Steering Committee. "The workshop is an open process. The more people that participate in this workshop, the better the quality of the workshop’s recommendations for science based changes to regulations."

The workshop is targeted toward individuals workingin the pharmaceutical industry involved with the development, manufacture, validation, and regulatory approval of powder blends and solid dosage forms.

The workshop will:

• Provide a public forum for debate of batch homogeneity issues and establish a common understanding of the scientific principles;
• Discuss current status and identify scientific andregulatory gaps that exist;
• Provide preliminary recommendations for science based changes to guidelines/regulations; and
• Identify data and research needed to support recommendations for change.

About PQRI

PQRI is a collaborative effort by FDA’s Center for DrugEvaluation and Research (CDER), industry and academia to examine and supportdrug regulatory issues. PQRI consists of a board of directors, a scientificsteering committee, technical committees and working groups. The five-memberboard of directors oversees the administrative management and operationsof the institute. The board has authority over the collection and disbursementof funds and the administrative procedures required to guarantee effectiveoperations.

The steering committee oversees all aspectsof the institute, including the selection of research topics, approvalof study protocols and reports, and making final recommendations to FDAbased on the outcome of PQRI research. Technical committees are formedby the steering committee and charged with development of PQRI researchprograms and projects. The technical committees oversee formulation ofthe direction for research projects; establishment of appropriate workinggroups; and monitoring of research projects as well as supporting researchdata. Under the direction of the technical committees, working groupswill further develop and execute specific research proposals. The ultimategoal of these working groups is to develop scientific knowledge that willresult in appropriate changes to regulatory policies that will, in mostcases, be less burdensome.

For additional information about PQRI, visit www.pqri.org.For more information on the workshop, log on to www.pqri.org/events/blend.

About AAPS

PQRI is administratively managed by AAPS. AAPS is a professional,scientific society of more than 10,000 members employed in academia, industry,government and other research institutes worldwide. Founded in 1986, AAPSaims to advance science through the open exchange of scientific knowledge,serve as an information resource, and contribute to human health throughpharmaceutical research and development. For more information about AAPS,visit AAPS Online at www.aaps.org.

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