News Release

PQRI workshop to address blend uniformity

Meeting Announcement

American Association of Pharmaceutical Scientists

The Product Quality Research Institute (PQRI) Workshop on Blend Uniformity will take place 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 working in 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 and regulatory gaps that exist;
  • Provide preliminary recommendations for science based changes to guidelines/regulations; and
  • Identify data and research needed to support recommendations for change.

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About PQRI
PQRI is a collaborative effort by FDA's Center for Drug Evaluation and Research (CDER), industry and academia to examine and support drug regulatory issues. PQRI consists of a board of directors, a scientific steering committee, technical committees and working groups. The five-member board of directors oversees the administrative management and operations of the institute. The board has authority over the collection and disbursement of funds and the administrative procedures required to guarantee effective operations.

The steering committee oversees all aspects of the institute, including the selection of research topics, approval of study protocols and reports, and making final recommendations to FDA based on the outcome of PQRI research. Technical committees are formed by the steering committee and charged with development of PQRI research programs and projects. The technical committees oversee formulation of the direction for research projects; establishment of appropriate working groups; and monitoring of research projects as well as supporting research data. Under the direction of the technical committees, working groups will further develop and execute specific research proposals. The ultimate goal of these working groups is to develop scientific knowledge that will result in appropriate changes to regulatory policies that will, in most cases, be less burdensome.

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

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, AAPS aims to advance science through the open exchange of scientific knowledge, serve as an information resource, and contribute to human health through pharmaceutical research and development. For more information about AAPS, visit AAPS Online at www.aaps.org.


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