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International Workshop on Alternative Methods for Human and Veterinary Rabies Vaccine TestingThe National Toxicology Program Interagency Center for the Evaluation of Alternative Toxicological Methods (NICEATM) will convene an "International Workshop on Alternative Methods for Human and Veterinary Rabies Vaccine Testing: State of the Science and Planning the Way Forward" on October 11-13, 2011, at the U.S. Department of Agriculture Center for Veterinary Biologics in Ames, Iowa. NICEATM and the Interagency Coordinating Committee on the Validation of Alternative Methods (ICCVAM) are organizing the workshop in conjunction with the European Centre for the Validation of Alternative Methods, the Japanese Center for the Validation of Alternative Methods, and Health Canada. This workshop will bring together scientists from government, industry, and academia to review the available methods and approaches that may reduce, refine, and replace the use of animals for human and veterinary rabies vaccine potency testing. Participants will then develop an implementation strategy to achieve global acceptance and use of these alternatives. Confirmed and invited speakers for the workshop include representatives from the U.S. Food and Drug Administration, the U.S. Department of Agriculture, the Centers for Disease Control and Prevention, the World Health Organization, the World Animal Health Organization, and the Paul-Ehrlich-Institut, along with industry representatives from Merial, Sanofi, and Intervet/Schering-Plough. A poster session planned for the workshop will highlight presentations on current research, development, validation, and/or regulatory acceptance of alternative methods that may reduce, refine, and/or replace the use of animals in rabies vaccine potency testing. The workshop is open to the public at no charge with attendance limited only by the available space. However, all attendees to the workshop must preregister with NICEATM (see below). Abstracts for scientific posters for display at the workshop are also invited. Abstracts for the poster session should be submitted to NICEATM by September 16, 2011. An updated agenda for the workshop, including names of confirmed speakers, is available on the NICEATM-ICCVAM web site. Plenary sessions will include reviews of current practices and regulations for rabies vaccine potency testing, opportunities for reduction and refinement of animal use in currently available in vivo assays, and available non-animal methods and strategies for rabies vaccine potency testing. Breakout sessions will be directed at defining the efforts necessary to achieve global acceptance and implementation of available alternative methods. BackgroundRabies is one of the oldest known zoonotic diseases and is responsible for at least 55,000 human deaths worldwide each year. Rabies vaccines serve a vital role in preventing further deaths and controlling the disease in certain animal populations. An estimated 15 million people receive post-exposure vaccine prophylaxis each year due to actual or suspected exposures to the rabies virus. In the United States and other developed countries, rabies vaccines have effectively eliminated domestic rabies virus strains. Prior to the release of each production lot of vaccine, regulatory authorities require demonstration of potency and safety. Potency and safety testing of rabies vaccines requires large numbers of laboratory animals and involves significant pain and distress. New methods and NICEATM, ICCVAM, and their international partners convened an international workshop on vaccine potency and safety testing in September 2010. Participants in this workshop identified rabies vaccines as one of the three highest priorities for future research, development, and validation of alternative test methods that could further refine, reduce, and ultimately replace animal use for this purpose. One of the highest priority implementation activities was organization of an international workshop on alternative methods for rabies vaccine potency testing. Based on recent scientific and technological advances, several alternative approaches have been proposed or are currently available. This international workshop will bring together scientific experts from government, industry, and academia to review these methods and to define efforts necessary to achieve global acceptance and implementation. The workshop will identify critical components of manufacturing processes necessary to demonstrate batch to-batch consistency and how monitoring these components can be used with in vivo and in vitro potency tests in an integrated approach to reduce and replace animal use for rabies batch release. Workshop participants will also identify the most appropriate source(s) for reference reagents to ensure standardization of in vitro rabies potency testing methods. Registration and Abstract SubmissionInformation including the draft agenda and a link to online registration is available on the NICEATM-ICCVAM website.Those planning to attend the workshop are asked to preregister by September 30, 2011. Please note that late registration at the workshop will not be available, as U.S. Department of Agriculture securityrequires that all attendees must preregister. NICEATM and ICCVAM also invite the submission of abstracts for scientific posters to be displayed during this workshop. Abstracts should be submitted by September 16, 2011. Abstract submission guidelines are available on the NICEATM-ICCVAM web site at the address listed above. If you have questions about the workshop or would like more information, please contact NICEATM at niceatm@niehs.nih.gov. About NICEATM and ICCVAMICCVAM is an interagency committee composed of representatives from 15 U.S. Federal regulatory and research agencies that require, use, generate, or disseminate toxicological and safety testing information. ICCVAM conducts technical evaluations of new, revised, and alternative safety testing methods with regulatory applicability. ICCVAM also promotes the scientific validation and regulatory acceptance of safety testing methods that more accurately assess the safety and health hazards of chemicals and products and that reduce, refine (decrease or eliminate pain and distress), or replace animal use. NICEATM administers ICCVAM and provides scientific and operational support for ICCVAM-related activities. NICEATM also conducts independent validation studies to assess the usefulness and limitations of new, revised, and alternative test methods and strategies. ICCVAM has contributed to the approval or endorsement of over 40 alternative safety-testing methods by Federal regulatory agencies and international organizations since its establishment in 1997. Appropriate use of these test methods can significantly reduce animal use and improve animal welfare. ICCVAM has also identified critical research, development, and validation efforts needed to further advance numerous other alternative methods. NICEATM and ICCVAM welcome nominations and submissions of alternative safety testing methods for validation studies and/or technical evaluations. Nominations and submissions are welcome from any individual or organization. Please contact NICEATM at niceatm@niehs.nih.gov for more information or to discuss a possible nomination or submission. Additional information about other NICEATM and ICCVAM activities can be found on the NICEATM-ICCVAM website. Thank you for your interest and your support of NICEATM and ICCVAM. Catherine Sprankle |
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