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PAPERBACK list:$21.00 Web:$18.90 add to cart Rights & Permissions Free PDF Access Free Resources Sign in to download PDF book and chapters PDF EXECUTIVE SUMMARY Display this book on your site! Related Titles The Future of Drug Safety: Promoting and Protecting the Health of the Public Emergency Care for Children: Growing Pains Other Related Titles Addressing the Barriers to Pediatric Drug Development: Workshop Summary (2008) Board on Health Sciences Policy (HSP) Web Search Builder Use this book's key terms to search within this book, across our collection, or across the Web. Skim This Chapter Skim this chapter and use this chapter's key terms to search within this book. Reference Finder Paste in your own text to find books that relate to your topic. Page 43   E-mail  Facebook  Digg  Stumble  Twitter More The following HTML text is provided to enhance online readability. Many aspects of typography translate only awkwardly to HTML. Please use the page image as the authoritative form to ensure accuracy. Appendix A Workshop Agenda Forum on Drug Discovery, Development, and Translation Addressing the Barriers to Pediatric Drug Development June 13, 2006 8:00 am–4:30 pm The National Academies 7:30 am Breakfast 8:00 am Opening Remarks by Discussion Moderator   Michael Katz, MD March of Dimes Birth Defects Foundation Current Development Procedures and Impact on Clinical Practice 8:10 am Richard Gorman, MD American Academy of Pediatrics 8:25 am Wayne Snodgrass, MD, PhD American Academy of Pediatrics Committee on Drugs 8:40 am Discussion Regulatory Perspective 9:10 am Historical and Regulatory Background Lisa Mathis, MD U.S. Food and Drug Administration Page 43 Front Matter (R1-R12) Summary (1-6) 1 Introduction (7-9) 2 Regulatory Framework (10-19) 3 Current Challenges in Developing and Prescribing Drugs for Children (20-28) 4 Models for Enhancing Pediatric Drug Development (29-35) 5 Challenges and Opportunities for the Future (36-40) References (41-42) Appendix A: Workshop Agenda (43-45) Appendix B: Speaker Biographies (46-52)

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OCR for page 43
Addressing the Barriers to Pediatric Drug Development: Workshop Summary Appendix A Workshop Agenda Forum on Drug Discovery, Development, and Translation Addressing the Barriers to Pediatric Drug Development June 13, 2006 8:00 am–4:30 pm The National Academies 7:30 am Breakfast 8:00 am Opening Remarks by Discussion Moderator   Michael Katz, MD March of Dimes Birth Defects Foundation Current Development Procedures and Impact on Clinical Practice 8:10 am Richard Gorman, MD American Academy of Pediatrics 8:25 am Wayne Snodgrass, MD, PhD American Academy of Pediatrics Committee on Drugs 8:40 am Discussion Regulatory Perspective 9:10 am Historical and Regulatory Background Lisa Mathis, MD U.S. Food and Drug Administration

OCR for page 44
Addressing the Barriers to Pediatric Drug Development: Workshop Summary 9:25 am Relabeling of Existing Drugs William Rodriguez, PhD, MD U.S. Food and Drug Administration 9:40 am Lessons Learned and Future Directions Dianne Murphy, MD U.S. Food and Drug Administration 9:55 am Discussion 10:25 am Break Incentives and Disincentives for Pediatric Drug Development 10:40 am Ethical Issues Concerning Testing of New Drugs in Children Robert Nelson, MD, PhD Children’s Hospital of Philadelphia 10:55 am Natasha Jarrett Hoffmann-LaRoche 11:10 am Thomas Hassall, RPh, MS Abbott Laboratories 11:25 am Discussion 12:00 pm Lunch Dose Finding and Bioavailability Guessing 1:00 pm Robert Ward, MD University of Utah 1:15 pm Best Pharmaceuticals for Children Act: Pediatric Formulation Issues George Giacoia, MD National Institute of Child Health and Human Development, National Institutes of Health 1:30 pm Discussion

OCR for page 45
Addressing the Barriers to Pediatric Drug Development: Workshop Summary Could Vaccines Be a Possible Model for Pediatric Drug Development? 2:00 pm Walter Orenstein, MD Vaccine Adverse Event Reporting System 2:15 pm Discussion 2:45 pm Break Current Models and Alternative Approaches 3:00 pm European Union Legislation Annic Weyersberg, MD European Agency for the Evaluation of Medicinal Products 3:15 pm St. Jude’s Approach to Addressing the Institute of Medicine Report: Making Better Drugs for Children with Cancer William Evans, PharmD St. Jude Children’s Research Hospital 3:30 pm Discussion Identification of Actions 4:00 pm Conclusions and Next Steps for the Institute of Medicine Drug Forum 4:30 pm Adjourn