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Second Meeting October 22-23, 2003 Washington, DC |
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| Agenda | ||
| Minutes | ||
| Webcast | October
22 morning (before break) October
22 morning (after break)
October 22 afternoon (before break) October 22 afternoon (after break) October 23 morning (before break) October 23 morning (after break) |
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| Webcasts can be viewed by downloading RealOne player. | ||
| Transcripts | October 22 October 23 | |
| Slides and transcripts are in pdf format. A free pdf reader is available here.
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| Oversight of Genetic Technologies, Marketing, and Laboratories and the Role of Pharmacogenetic Tests in Therapeutics | |
| Oversight
of Genetic Testing Laboratories Through the Clinical Laboratory
Improvement Amendments (CLIA) Judith A. Yost, M.A., M.T. Director, Division of Laboratories and Acute Care Centers for Medicare & Medicaid Services slides webcast transcript |
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| Plans
for Augmenting CLIA to Specifically Address Genetic Testing Laboratory
Issues and Concerns D. Joe Boone, Ph.D. Associate Director for Science, Division of Laboratory Systems Public Health Practice Program Office Centers for Disease Control and Prevention slides webcast transcript |
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| Roundtable
Discussion Facilitator: Dr. Winn-Deen webcast transcript |
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| Impact
of Pharmacogenomics on Prescription Drug Labeling Lawrence J. Lesko, Ph.D. Director, Office of Clinical Pharmacology and Biopharmaceutics Center for Drug Evaluation and Research Food and Drug Administration slides webcast transcript |
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| FDA's
Current Approach to the Review, Labeling and Marketing of Genetic Tests Steven I. Gutman, M.D. Director, Office of In Vitro Diagnostics Center for Devices and Radiological Health Food and Drug Administration slides webcast transcript |
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| FDA's
Future Plans to Enhance Oversight of High Risk Genetic Tests David W. Feigal, Jr., M.D., M.P.H. Director, Center for Devices and Radiological Health Food and Drug Administration slides webcast transcript |
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| Roundtable
Discussion Facilitator: Dr. Leonard webcast transcript |
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| FTC's
Regulation of the Advertising and Promotion of Consumer Products and Its
Application to Genetic Technologies Matthew Daynard, J.D. Senior Attorney, Advertising Practices Division Bureau of Consumer Protection Federal Trade Commission slides webcast transcript |
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| Roundtable
Discussion Regarding FDA and FTC Regulation of Advertising and Promotion
of Genetic Technologies Facilitator: Ms. Zellmer webcast transcript |
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| Public Comment Session | |
| Continued Discussion of Oversight and Pharmacogenetics | |
| Genetic Discrimination in Health Insurance and Employment | |
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Update
on the Status of Federal Legislation to Prohibit Genetic Discrimination Roundtable
Discussion
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| Thursday, October 23, 2003 | |
| Other Nations' Approaches to Addressing Issues Involving Genetic Technologies | |
| Human
Genetics Commission, United Kingdom Mr. Philip Webb Member, Human Genetics Commission slides webcast transcript |
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| Australian
Law Reform Commission David Weisbrot, J.D. President, Australian Law Reform Commission slides webcast transcript |
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| Roundtable
Discussion Facilitator: Dr. Hook |
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| Genetics Workforce, Education, and Training | |
| Framing
the Issues Joann Boughman, Ph.D. Executive Vice President, American Society of Human Genetics Chair, Former SACGT Education Work Group slides webcast transcript |
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| Federal
Efforts to Address Genetics Workforce, Education, and Training Issues Sam Shekar, M.D., M.P.H. Associate Administrator, Bureau of Primary Health Care Health Research and Services Administration slides webcast transcript |
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| Preliminary
Findings of the Genetics Workforce Study Judith A. Cooksey, M.D., M.P.H. Adjunct Associate Professor, Department of Epidemiology and Preventive Medicine University of Maryland School of Medicine slides webcast transcript |
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| Roundtable
Discussion Facilitator: Dr. Willard webcast transcript |
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| Public Comment Session | |
| Genetics Workforce, Education, and Training (continued) | |
| Overview
of Efforts by Organizations and Professional Societies to Address
Genetics Workforce, Education, and Training Issues Joann A. Boughman, Ph.D. Executive Vice President, American Society of Human Genetics Chair, Former SACGT Education Work Group slides webcast transcript |
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| Educational
Programs for Health Professionals: Addressing the Gaps Joseph D. McInerney, M.S. Director National Coalition for Health Professional Education in Genetics slides webcast transcript |
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| Genetic
Counselor Training Program Capacities and Needs Robin Bennett, M.S., CGC Past President I National Society of Genetic Counselors slides webcast transcript |
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| Roundtable
Discussion Facilitator: Dr. Tuckson webcast transcript |
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| SACGHS Discussion of Next Steps and Plans for the March 1-2, 2004 Meeting | |
| Closing
Remarks Dr. McCabe |
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