WHO: The American Association of Pharmaceutical Scientists (AAPS) is a professional, scientific society of approximately 12,000 members employed in industry, academia, government and other research institutes worldwide. Founded in 1986, AAPS provides a dynamic international forum for the exchange of knowledge among scientists to enhance their contributions to public health. AAPS offers timely scientific programs, on-going education, information resources, opportunities for networking, and professional development.
WHAT: AAPS is pleased to present the free eLearning opportunity Criteria for FDA’s Acceptance of Results from Pharmacometrics Approaches. This module is being organized by the AAPS Pharmacokinetics, Pharmacodynamics and Drug Metabolism (PPDM) section and will be conducted by Joga Gobburu, Ph.D. WHY: This Webinar will provide a historical perspective on modeling and simulation (M&S) submissions to the U.S. Food and Drug Administration (FDA). It will also cover strategies used to increase the likelihood that M&S results will be acceptable for FDA review, and answer critical questions related to what should be included in the submission, how are different approaches looked upon at FDA, and what FDA reviewers look for. WHEN: June 2, 2011 12:45 PM to 2:15 PM EDT
CONTACT: For additional information about the Webinar, and to register, visit http://www.aapspharmaceutica.com/fdaacceptance. For questions or to set up an interview with the conductor please contact Joe Catapano at 703-248-4772 or [email protected].
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