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Full Description
Throughout the world, ‚traditional' vaccines have been developed to help control animal diseases. The majority are licensed or registered under a standard set of provisions developed by regulatory authorities. However, there are animal health situations, such as minor species use or minor indications (MUMS), where traditional vaccines have not always been available, or products have not performed as expected, and alternatives such as autogenous/autologous vaccines are sought. Vaccines for MUMS and autologous/ autogenous vaccines therefore present unique licensing and registration issues and are not always allowed by regulatory authorities. This volume presents the proceedings of a meeting held in Langen, Germany, in October 2003, which provided a platform for the exchange of regulatory and field experiences in the USA and Europe. Intense discussions led to conclusions which formed the basis on which, in the wake of this meeting, standards for autologous/autogenous vaccines and products for MUMS can be revised. We have come one step closer to our aim of making sure that even for smaller market segments vaccines of all kinds and in good quality are available. In the meantime, further action for the realization of this aim is ongoing in different committees.
Contents
Opportunities and Expectations: Espeseth, D.A. Autogenous/Autologous Vaccines Legal Basis and Definitions: Views from Authorities, Field and Industry Regulation of Autogenous Biologicals in the United States: Schmelli k-Sandage, C.S.; Hill, R.E., Jr. Autogenous Vaccines: the Legal Basis and Regulation in the United K ingdom: Ilott, M. Veterinary Autogenous Vaccines: Hera, A.; Bures, J. Autogenous Vaccines: Industry Proposals for Procedures and Requirem ents: Zanker, S. Identification of Suitable and Needed Antigens and Criteria for Quality of Production and Control Autologous Biologicals - Science/Regulations: Chapek, M.L.; Brown, K.K.; Lin, B.C. Autogenous Vaccines: Determining Product Need and Antigen Selection, Production and Testing Considerations: Draayer, H.A. The Manufacture of Autogenous Vaccines in France: Miras, C. Current Concepts and Future Approaches to the Development of Autolo gous/Autogenous Vaccines for Veterinary Use: Tollis, M. Actual Situation and Handling in the Field: Producers' and Users' Point of View Autogenous Vaccines: Current Use Patterns and End Users' Needs in t he Integrated Broiler Industry: Smith, J.A. Autogenous Vaccines: Current Use in the Field in the U.S. Cattle an d Hog Industry: Chase, C.C.L. Current Situation and Use of Autogenous Vaccines in France: The Vie ws of the Manufacturer and the User: Thibault, E. Manufacturing and Use of Autologous Vaccines in Germany - Experienc e of a Vaccine Manufacturer: Neubert, A. Vaccines for Minor Use and Minor Species Introduction, Producers' and Veterinarians' Point of View Minor Species/Minor Indications - Introductory Remarks: Jungback, C. Minor Species, Who Cares? Aerts, M.M.L. Conditional Licensing of Veterinary Biologicals in the United State s: a Major Manufacturer's Perspective: Carlson, M.M.; Chiang, Y.-W.; Chu, H.-J. Vaccines for Minor Use and Minor Species (MUMS) - Industry's Views: Bonisch, B. A Small Manufacturer's Perspective on Small Volume Products: Huff, J.N. Consideration of Alternative Licensing Procedures for Vaccines for Minor Species and Minor Indications - Manufacturer's Point of View: de Foucauld, J. Vaccine Use and Abuse: a Practitioner's Viewpoint: Moore, G.A. Necessary Changes in Legal Provisions Minor Species/Minor Indications: Legal Provisions, Definition Crite ria and Policies to Be Considered: Papadopoulos, O. Vaccines for Minor Use and Minor Species: Technical Difficulties to Solve and Consequences in Legal Definitions: Vannier, P. Vaccines for Minor Use/Minor Species (MUMS) in the European Union: Mackay, D. Legal Basis, Definitions, Need for Availability and the Role of Conditional Licences: Authorities' Point of View Regulation of Conditionally Licensed Biologicals in the United Stat es: Hill, R.E. Consideration of Alternative Licensing Procedures for Vaccines for Minor Species, Minor Indications and Autogenous/Autologous Products: Jones, P.G.H. Use of Vaccines for Minor Species - Minor Indications: Soos, T. Vaccines for Minor Species and Minor Indications: Current Situation and Concepts in Germany - Feasible Approaches for the Future - Aut horities' View: Werner, E.
