Preliminary Program - American Association of Pharmaceutical ...

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76 2009 AAPS Annual Meeting and Exposition AAPS Pharmacokinetics, Pharmacodynamics and Drug Metabolism (PPDM) Programming In addition, recent technological developments such as MALDI and AMS will be discussed. Are these newer technologies for drug metabolism really useful and how do they provide additional understanding of the drug’s metabolism and distribution? Why do various Pharma companies conduct drug metabolism research differently? Is cost a principle factor that drives how small or big companies approach metabolism issues? What are the pros and cons of NMR based methods? Can or should “light-label” ADME studies replace the conventional 14C mass balance approach? These and your questions about metabolism studies are the basis for the PPDM Open Forum. There likely will never be an absolute answer to many of these perplexing questions but through an open debate and dialog each participant can begin to narrow down the extensive array of possible answers based upon the collective experience of colleagues across the diverse pharmaceutical industry that includes regulatory and academic institutions. A consensus among scientific colleagues can be a powerful tool for reaching a pragmatic basis that leads to the implementation of appropriate technologies and leverages specific study designs that yield scientifically robust results maintaining the rigorous standards set within a regulatory framework. The PPDM Open Forum will be an opportunity for a dynamic exchange of ideas and thoughts about the current status and future opportunities for metabolism studies. We will have a panel of experts to engage all the participants in a lively exchange of ideas, challenges, proposals, and discourse. Don’t miss this chance to understand the new opportunities embodied in MALDI and AMS as well as the occasion to discuss with your colleagues the significant challenges that lie ahead for anyone involved in drug metabolism research. Please plan to join us at the PPDM Open Forum in Los Angeles. Bring your most challenging questions, your most perplexing problems, and most of all your passion for seeking meaningful answers that help to point the path forward to the next generation of metabolism research strategies. Moderators Richard F. Bergstrom, Ph.D. RFBergstrom PK/PD Consulting LLC Sriram Krishnaswami, Ph.D. Pfizer Global Research & Development Bernd Meibohm, Ph.D. University of Tennessee Health Science Center Raimund M. Peter, Ph.D. AstraZeneca Raman Venkataramanan, Ph.D., M.S. University of Pittsburgh Bonnie A. Avery, Ph.D. University of Mississippi Lloyd Stevens, Ph.D. Pharmaceutical Profiles Limited Lane J. Brunner, Ph.D. Regis University
77 2009 AAPS Annual Meeting and Exposition AAPS Regulatory Sciences (RS) Programming at a glance Monday Tuesday Wednesday Thursday 8:30 am – 11:00 am Wednesday Morning Symposia Funded by a Grant from 9:00 am – 11:00 am Roundtables Impact of Changing Regulations on Postapproval CMC Changes: U.S. and E.U. Perspectives How to Face and Successfully Defend FDA and Other Regulatory Audits Symposium The Influence of Excipient Functionality on Quality by Design for Drug Product 2:00 pm – 4:00 pm Roundtable Navigating the New Rules Regarding Patent Law: Decodifying ‘Obviousness’, ‘Limited Claims’, and How it Affects New Composition of Matter Patents 2:00 pm – 4:30 pm Monday Afternoon Symposia Funded by a Grant from Symposium Regulatory Significance of Critical Quality Attributes and Critical Process Parameters in Successful Product Development and Commercialization 2:00 pm – 4:00 pm Tuesday Afternoon Roundtables Funded by a Grant from Roundtables Stability Evaluations Using Alternate Accelerated Conditions Bioequivalence Requirements: Challenges in Global Drug Development and Harmonization 2:00 pm – 4:00 pm Roundtable Comparator Products – Untold Stories 2:00 pm – 4:30 pm wednesday afternoon symposia funded by a grant from Symposia Using the Quality-by-Design Principle to Establish Pharmaceutical Equivalence and Bioequivalence of Advanced Dosage Forms Microdialysis Role in the Development and Optimization of Drug Topical Delivery 1:30 pm – 5:00 pm Open Forums Global Regulatory Challenges for Genotoxic Impurities An additional fee is required to attend this open forum Biosimilars- Development Considerations and Future Directions (BIOTEC & RS) An additional fee is required to attend this open forum 5:30 pm – 7:30 pm Regulatory Sciences (RS) Section Joint Membership Meeting and Reception
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