The American Association of Pharmaceutical Scientists (AAPS) will present the AAPS Workshop on Reference Standards: Science, Methodologies and Compliance of Current and Emerging Pharmaceutical Products, May 15-16, 2000 at the Crystal Gateway Marriott in Arlington, Va.

"This is the first workshop in several years dedicated exclusively to pharmaceutical reference standards," said Moheb M. Nasr, Ph.D., Food and Drug Administration. "This workshop will not only educate new scientists but will also provide more experienced scientists and managers a forum for discussion."

The objective of the workshop is to provide an update on current and emerging issues in the development, characterization and use of reference standards. The workshop will be of particular interest to pharmaceutical scientists working in analytical research and development, quality assurance and control, regulatory affairs and compliance and related disciplines.

Workshop topics include:

• Evolution of reference standards throughout drug discovery, development and post-marketing
• Characterization of Reference Standard Materials using a variety of analytical techniques
• Compendial review of and approval process (U.S. Pharmacopeia and International Pharmacopeias)
• Practical considerations for a successful reference standard program: maintenance, storage, use and requalification
• Reference standards used in the analysis of biotechnological and botanical drug products.
• Use of reference standards in comparitor studies for New Chemical Entities Reference standards used in the calibration and qualification of laboratory instruments
• Analytical approaches when reference standards are not available

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