ARLINGTON, Va. -The American Association of Pharmaceutical Scientists (AAPS) will present the AAPS Workshop on Analytical Methods Post Approval Changes and Packaging Post Approval Changes, May 31-June 2, 2000 at the Crystal Gateway Marriott in Arlington, Va. The workshop is co-sponsored by the FDA.

"Attendees at this workshop will have the opportunity to give FDA their views on post approval changes to analytical methodology and container closure systems," said Eric B. Sheinin, Ph.D., FDA. "The agency (FDA) is prepared to begin development of guidances in these two areas and welcomes input from interested parties."

The objectives of the workshop are:

To provide a forum for discussion of scientific issues related to changes in analytical methodologies and packaging for pharmaceuticals; To explore viable scientific approaches for the prediction of the potential impact of these changes on drug substances and drug product quality; and To generate a summary report that can be utilized by the FDA in the development of guidances on post approval changes in these areas.

Speakers at the meeting include: Vinod P. Shah, Ph.D., FDA; Dhiren N. Shah, Ph.D., Aventis Pharmaceuticals; Donald N. Klein, Ph.D., FDA; and Richard Hollander, Pfizer, Inc.

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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Contact: Debbie Mierke
mierke@aaps.org
703-248-4743
American Association of Pharmaceutical Scientists
15-May-2000