Strengthening a Workforce for Innovative Regulatory Science in Therapeutics Development Workshop Summary (2012) / Chapter Skim
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Appendix A: Workshop Agenda
Appendix A: Workshop Agenda
Pages 67-80
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From page 67... ...
, described regulatory science as a sciencebased decision-making process needed to fulfill the responsibilities of a public health agency: "FDA must have the scientific staff and resources to undertake the regulatory research that will provide a basis to: (1) improve capacity for safety and efficacy evaluations and monitoring of candidate and licensed products; (2)
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consider opportunities and needs for advancing innovation in the discipline of regulatory science for therapeutics devel opment through an interdisciplinary regulatory science workforce and (2) examine specific strategies for developing a discipline of innovative regulatory science through development of a robust workforce within academia and industry and at FDA.
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SEPTEMBER 20, 2011 8:30 a.m. Welcome and Introductions Barry Coller, Workshop Co-Chair Vice President for Medical Affairs and Physician-in-Chief David Rockefeller Professor The Rockefeller University elaine Gallin, Workshop Co-Chair Principal QE Philanthropic Advisors Session I: Defining a Discipline of Regulatory Science Session Objectives: • Discuss the promise of and role for innovative regulatory science in therapeutics development.
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• ropose and discuss the essential, core components of P a robust discipline of innovative regulatory science in therapeutics development. • ist key skills, techniques, and areas of expertise needed L by a regulatory science workforce.
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Therapeutics Development Mary dwiGht Vice President for Government Affairs Cystic Fibrosis Foundation 10:50 a.m. Drug Safety Munir pirMohaMed Deputy Director MRC Centre for Drug Safety Science, University of Liverpool 11:10 a.m.
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Mary dwiGht Vice President for Government Affairs Cystic Fibrosis Foundation Clifford lane Deputy Director for Clinical Research and Special Projects National Institute of Allergy and Infectious Diseases National Institutes of Health Munir pirMohaMed Deputy Director MRC Centre for Drug Safety Science, University of Liverpool Melinda wharton Deputy Director, National Center for Immunization and Respiratory Diseases Centers for Disease Control 12:40 p.m. LUNCH Session III: Education and Training of a Regulatory Science Workforce Session Objectives: • Discuss education and training opportunities needed to develop a robust workforce in regulatory science in therapeutics development.
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annette Mollet European Center of Pharmaceutical Medicine University of Basel, Switzerland 2:30 p.m. Panel Discussion with Speakers alaStair wood, Panel Moderator Partner & Managing Director Symphony Capital LLC 3:00 p.m.
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Jonathan wieSt Director for Training and Education, Center for Cancer Research Office of Training and Education, National Cancer Institute National Institutes of Health 4:20 p.m. henrietta ukwu Senior Vice President for Global Regulatory Affairs PPD, Inc.
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ADJOURN SEPTEMBER 21, 2011 8:30 a.m. Welcome and Introductions Workshop Co-Chairs Barry Coller Vice President for Medical Affairs and Physician-in-Chief David Rockefeller Professor The Rockefeller University elaine Gallin Principal QE Philanthropic Advisors Session V: International Applications elaine Gallin, Session Chair Principal QE Philanthropic Advisors 8:35 a.m.
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Barry Coller, Session Chair Vice President for Medical Affairs and Physician-in-Chief David Rockefeller Professor The Rockefeller University 9:15 a.m. GiGi hirSCh Program Director, NEWDIGS Executive Director, Center for Biomedical Innovation Massachusetts Institute of Technology 9:30 a.m.
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lawrenCe deyton Director Center for Tobacco Products Food and Drug Administration FDA Commissioner's Fellows Program uroS dJekiC Commissioner's Fellow (2008-2010) Senior Regulatory Reviewer/Policy Analyst Center for Biologics Evaluation and Research Food and Drug Administration CBER Regulatory Science Activities Carolyn wilSon Associate Director for Research Center for Biologics Evaluation and Research Food and Drug Administration Visiting Lecturer/Expert Programs at FDA kate ahlport Executive Director Health Research Alliance FDA Rotation for Clinical Research Fellows at the NIH Clinical Center Juan lertora Director Clinical Pharmacology Program NIH Clinical Center 10:45 a.m.
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11:00 a.m. Discussion with Panelists and Workshop Attendees Led by Workshop Co-Chairs Barry Coller, Workshop Co-Chair Vice President for Medical Affairs and Physician-in-Chief David Rockefeller Professor The Rockefeller University elaine Gallin, Workshop Co-Chair Principal QE Philanthropic Advisors SteVen GalSon Vice President for Global Regulatory Affairs Amgen Inc.
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79 APPENDIX A theodore reiSS Research Professor of Medicine Vanderbilt University School of Medicine 12:00 p.m.
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