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| Workshops, Safety Symposia and Policy Conferences |
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Workshops |
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Upcoming Workshops and Training Sessions
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Safety and Scientific Symposia |
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Safety Symposium - March 15, 2005
Current Perspectives on Gene Transfer for X-SCID
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Safety Symposium - September 21-22, 2004
Safety Considerations in Recombinant DNA Research with Pathogenic Viruses
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Safety Symposium - March 7, 2001
Safety Considerations in the Use of AAV Vectors in Gene Transfer Clinical Trials
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Safety Symposium - December 14, 2000
Safety Considerations in Cardiovascular Gene Transfer Clinical Research
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Safety Symposium - March 8, 2000
Internally Deleted, Helper-Dependent Adenoviral Vectors
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Biosafety Considerations for Research with Lentiviral Vectors |
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Policy Conferences |
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NIH Public Consultation on Proposed Changes to the NIH Guidelines for Synthetic Nucleic Acids (June 23, 2009) |
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Summaries and Reports of the Gene Therapy Policy Conferences (1998-Present)
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IBCs in a Changing Research Landscape: A Policy Conference
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Past Professional Development Conferences, Workshops, and Training Sessions |
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Institutional Biosafety Committees: Promoting Optimal Practice Now and in the Future
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The NIH System of Oversight of Human Gene Transfer Research: Optimizing Science, Safety and Ethics
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IBC Basics: An Introduction to the NIH Guidelines and the Oversight of Recombinant DNA Research
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The Future Face of IBCs: Evolving Roles and Responsibilities, Upcoming Challenges and Opportunities
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Upcoming Exhibits, Workshops and Training Sessions |
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OBA will be conducting exhibits, workshops, training sessions, and presentations at the following meetings:
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Public Responsibility in Medicine and Research,"IBC Basics: An Introduction to the NIH Guidelines and the Oversight of Recombinant DNA Research,"
September 22, 2009, Cambridge, Massachusetts
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American Biological Safety Association, Exhibit and IBC Training Course,
October 18-21, 2009, Miami, Florida
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Safety Symposium - March 15, 2005: |
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Current Perspectives on Gene Transfer for X-SCID
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Webcast - Morning session before break |
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Webcast - Morning session after break |
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Webcast - Afternoon session before break |
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Webcast - Afternoon session after break |
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Current Perspectives on Gene Transfer for X-linked Severe Combined Immunodeficiency Disease (X-SCID) |
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Safety Symposium - September 21-22, 2004: |
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Safety Considerations in Recombinant DNA Research with Pathogenic Viruses
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On September 21-22, 2004, NIH OBA held a safety symposium in conjunction with the meeting of the Recombinant DNA Advisory Committee (RAC). The symposium addressed safety considerations for recombinant DNA research with pathogenic viruses, focusing on containment issues for research with such viruses as 1918 influenza virus, highly pathogenic avian influenza viruses, and SARS Co-V. A major goal of the symposium was to develop a Points to Consider document and other resources to assist IBCs in conducting risk assessments and determining appropriate containment.
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Agenda and Participant List |
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Webcast - Day one - Morning session before break |
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Webcast - Day one - Morning session after break |
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Webcast - Day one - Afternoon session before break |
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Webcast - Day one - Afternoon session after break |
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Reference Information |
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Frequently Asked Questions - Risk Assessment and Determining Containment |
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Safety Symposium - March 7, 2001: |
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Safety Considerations in the Use of AAV Vectors in Gene Transfer Clinical Trials
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Transcript |
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Safety Symposium - December 14, 2000: |
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Safety Considerations in Cardiovascular Gene Transfer Clinical Research
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Transcript |
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Safety Symposium - March 8, 2000: |
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Internally Deleted, Helper-Dependent Adenoviral Vectors
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Transcript |
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Summary |
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Summaries and Reports of the Gene Therapy Policy Conferences (1998-Present) |
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Prenatal Gene Therapy: Scientific, Medical, & Ethical Issues - January 7-8, 1999 |
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Full Report |
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Summary |
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RAC Statement Regarding In Utero Gene Transfer Research |
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Lentiviral Vectors for Gene Delivery - March 9, 1998 |
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Summary |
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Preclinical Safety Evaluation of Lentivirus Vectors: FDA Regulatory Expectations - Anne M. Pilaro, Ph.D. |
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"IBCs in a Changing Research Landscape: A Policy Conference" |
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Bethesda, Marriott, December 7-8, 2001 |
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Conference Summary |
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Webcasts Day 1 |
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Welcome |
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Session 1 |
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Session 2 |
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Session 3 |
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Session 4 |
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Webcasts Day 2 |
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Morning Session |
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Afternoon Session |
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Note: |
For reasons beyond the control of the NIH and the host of these video pages (Webconferences.com), the color quality in this video product is not optimal. Webconferences.com was not responsible for the video recording onsite, nor for the encoding for the web, of these files.
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Presentation Information |
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Institutional Biosafety Committees: Promoting Optimal Practice Now and in the Future
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Hyatt Regency Crystal City, Arlington, Virginia, June 24-26, 2009
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The NIH Office of Biotechnology Activities and the Eagleson Institute, with the participation of the American Association for Laboratory Animal Science, American Biological Safety Association, American Society for Microbiology, and Public Responsibility in Medicine and Research, are planning a professional development conference for Institutional Biosafety Committee members and staff. The conference, titled "Institutional Biosafety Committees: Promoting Optimal Practice Now and in the Future," will take place June 24-26 at the Hyatt Regency in Crystal City, Virginia. This event will also be of interest to biosafety professionals, research administrators, scientists, and others involved with recombinant DNA research.
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The NIH System of Oversight of Human Gene Transfer Research: Optimizing Science, Safety and Ethics |
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Washington State Convention and Trade Center, Seattle, Washington, May 30, 2007 |
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Segment I - The Fundamentals of Oversight: NIH and Local Review |
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Introduction to the NIH Office of Biotechnology Activities and the Resources OBA Offers Investigators |
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Overview of the Policy and Biosafety Framework for Human Gene Transfer Research: The NIH Guidelines for Research Involving Recombinant DNA Molecules |
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Institutional Biosafety Committees (IBCs): The Linchpin of Local Oversight |
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The "What, When and How" of Submitting Human Gene Transfer Protocols to the NIH OBA for Review by the Recombinant DNA Advisory Committee (RAC) |
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Safety and Annual Reporting; What to Report and How to Get the Most out of GeMCRIS, NIH OBA's Electronic Safety Reporting System |
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Segment II - Views from the Field |
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An Investigator's Perspective: How to Prepare for RAC Review |
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Informed Consent in Human Gene Transfer Trials |
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"IBC Basics: An Introduction to the NIH Guidelines and the Oversight of Recombinant DNA Research" |
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Town and Country Resort Hotel, San Diego, California, March 12, 2005 |
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NIH OBA presentations |
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Introduction to the NIH Office of Biotechnology Activities |
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The NIH Guidelines and IBC Responsibilities |
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The Recombinant DNA Advisory Committee |
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"The Future Face of IBCs: Evolving Roles and Responsibilities, Upcoming Challenges and Opportunities" |
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Town and Country Resort, San Diego, California |
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Training session for new IBC members and staff, February 20, 2003; |
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Webcasts |
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Welcome and Introduction to the National Institutes of Health Office of
Biotechnology Activities |
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History and Evolution of IBCs: Asilomar to the Present  |
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Overview of the Current NIH Guidelines |
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Requirements for IBCs in the NIH Guidelines |
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Review of the Recombinant DNA Advisory Committee and the Protocol Review Process |
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Ask the Faculty: Open Forum for Questions |
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Presentation Information |
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Main conference event, February 21-22, 2003 |
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Webcasts Day 1 |
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Welcome from the Conference Organizers  |
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Keynote Presentation: At the Cutting Edge of Biotechnology: Emerging Promises, and New Oversight Challenges, Theodore C. Friedmann, M.D. |
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Panel I: Biodefense Research, Select Biological Agents and Toxins, and IBCs |
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Luncheon Address - Today's IBC: A Report on a National Survey of IBCs |
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Panel II - When You've Seen One IBC, You've Seen One IBC: A Roundtable Discussion to Various Approaches to Review and Oversight |
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Webcasts Day 2 |
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Opening Address - Managing Biosafety Concerns in Human Gene Transfer Research  |
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The Ethics of Preclinical Recombinant DNA Research |
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Ethical Consideration in Human Gene Transfer Research |
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Presentation Information |
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