AAPS Workshop to Examine Changes in Analytical Methods and Packaging
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.
For more information on this workshop, including a complete preliminary
program, registration fees, and accommodations, visit AAPS Online at
www.aaps.org/edumeet/ampac.
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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