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Acciones esenciales en inmunización : una guía práctica de campo / / [grupo técnico de redacción, Murray Trostle ... and others]
Acciones esenciales en inmunización : una guía práctica de campo / / [grupo técnico de redacción, Murray Trostle ... and others]
Edizione [Edición en español.]
Pubbl/distr/stampa [Washington, D.C.] : , : U.S. Agency for International Development, , [2007]
Descrizione fisica 1 online resource (318 unnumbered pages) : color illustrations, color maps
Altri autori (Persone) TrostleRichard Murray <1946->
Soggetto topico Immunization of children
Immunization of children - Developing countries
Soggetto genere / forma Handbooks and manuals.
Formato Materiale a stampa
Livello bibliografico Monografia
Lingua di pubblicazione spa
Altri titoli varianti Immunization essentials
Record Nr. UNINA-9910698800403321
[Washington, D.C.] : , : U.S. Agency for International Development, , [2007]
Materiale a stampa
Lo trovi qui: Univ. Federico II
Opac: Controlla la disponibilità qui
The children's vaccine initiative [[electronic resource] ] : continuing activities : a summary of two workshops held September 12-13 and October 25-26, 1994 / / Greg W. Pearson, editor ; Steering Committee on the Children's Vaccine Initiative: Continuing Activities, Division of Health Promotion and Disease Prevention, Institute of Medicine
The children's vaccine initiative [[electronic resource] ] : continuing activities : a summary of two workshops held September 12-13 and October 25-26, 1994 / / Greg W. Pearson, editor ; Steering Committee on the Children's Vaccine Initiative: Continuing Activities, Division of Health Promotion and Disease Prevention, Institute of Medicine
Pubbl/distr/stampa Washington, D.C., : National Academy Press, 1995
Descrizione fisica 1 online resource (65 p.)
Disciplina 614.47
Altri autori (Persone) PearsonGreg W
HallCaroline Breese
Soggetto topico Vaccination of children
Vaccines
Immunization of children
Soggetto genere / forma Electronic books.
Formato Materiale a stampa
Livello bibliografico Monografia
Lingua di pubblicazione eng
Nota di contenuto ""The Children�s Vaccine Initiative: Continuing Activities""; ""Copyright""; ""Preface""; ""Contents""; ""Promise and Problems: Hib, Pneumococcal, and Meningococcal Vaccines in the Developing World""; ""INTRODUCTION""; ""ARI AND MENINGOCOCCAL MENINGITIS IN THE DEVELOPING WORLD""; ""DETERMINING VACCINE NEED""; ""OVERCOMING SCIENTIFIC AND TECHNOLOGICAL BARRIERS""; ""Pneumococcal Vaccines""; ""Meningococcal Vaccines""; ""PROVING VACCINE EFFICACY: THE CHALLENGE OF DEVELOPING-COUNTRY FIELD TRIALS""; ""The Public-/Private-Sector Interface""; ""INTRODUCING AN EFFECTIVE VACCINE""
""Involving the U.S. Public and Private Sectors in the CVI""""INTRODUCTION""; ""BRINGING CLARITY TO THE CVI “VISION�""; ""TRENDS IN THE GLOBAL VACCINE SITUATION""; ""Industry Characteristics""; ""Local Production and Self-Sufficiency""; ""RESHAPING THE EPI""; ""A ROLE FOR INDUSTRY""; ""Barriers to Participation""; ""FACILITATING GREATER U.S. INVOLVEMENT""; ""Differential Pricing""; ""Technology Transfer""; ""DISCUSSION SUMMARY""; ""Appendix A Promise and Problems: Hib, Pneumococcal, and Meningococcal Vaccines in the Developing World""; ""FINAL AGENDA""; ""Day 1""; ""Day 2""
""WORKSHOP SPEAKERS""""WORKSHOP PARTICIPANTS""; ""Staff""; ""Appendix B Involving the U.S. Public and Private Sectors in the CVI""; ""FINAL AGENDA""; ""Day 1""; ""Involving the U.S. Public and Private Sectors in the CVI""; ""WORKSHOP SPEAKERS""; ""COMMISSIONED PAPER""; ""WORKSHOP PARTICIPANTS""; ""Staff""; ""Appendix C Acronyms and Abbreviations""
Record Nr. UNINA-9910451792703321
Washington, D.C., : National Academy Press, 1995
Materiale a stampa
Lo trovi qui: Univ. Federico II
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The children's vaccine initiative : continuing activities : a summary of two workshops held September 12-13 and October 25-26, 1994 / / Greg W. Pearson, editor ; Steering Committee on the Children's Vaccine Initiative: Continuing Activities, Division of Health Promotion and Disease Prevention, Institute of Medicine
The children's vaccine initiative : continuing activities : a summary of two workshops held September 12-13 and October 25-26, 1994 / / Greg W. Pearson, editor ; Steering Committee on the Children's Vaccine Initiative: Continuing Activities, Division of Health Promotion and Disease Prevention, Institute of Medicine
Pubbl/distr/stampa Washington, D.C. : , : National Academy Press, , 1995
Descrizione fisica 1 online resource (x, 55 pages)
Disciplina 614.47
Altri autori (Persone) PearsonGreg W
HallCaroline Breese
Soggetto topico Vaccination of children
Vaccines
Immunization of children
Formato Materiale a stampa
Livello bibliografico Monografia
Lingua di pubblicazione eng
Nota di contenuto ""The Children's Vaccine Initiative: Continuing Activities""; ""Copyright""; ""Preface""; ""Contents""; ""Promise and Problems: Hib, Pneumococcal, and Meningococcal Vaccines in the Developing World""; ""INTRODUCTION""; ""ARI AND MENINGOCOCCAL MENINGITIS IN THE DEVELOPING WORLD""; ""DETERMINING VACCINE NEED""; ""OVERCOMING SCIENTIFIC AND TECHNOLOGICAL BARRIERS""; ""Pneumococcal Vaccines""; ""Meningococcal Vaccines""; ""PROVING VACCINE EFFICACY: THE CHALLENGE OF DEVELOPING-COUNTRY FIELD TRIALS""; ""The Public-/Private-Sector Interface""; ""INTRODUCING AN EFFECTIVE VACCINE""
""Involving the U.S. Public and Private Sectors in the CVI""""INTRODUCTION""; ""BRINGING CLARITY TO THE CVI VISION""; ""TRENDS IN THE GLOBAL VACCINE SITUATION""; ""Industry Characteristics""; ""Local Production and Self-Sufficiency""; ""RESHAPING THE EPI""; ""A ROLE FOR INDUSTRY""; ""Barriers to Participation""; ""FACILITATING GREATER U.S. INVOLVEMENT""; ""Differential Pricing""; ""Technology Transfer""; ""DISCUSSION SUMMARY""; ""Appendix A Promise and Problems: Hib, Pneumococcal, and Meningococcal Vaccines in the Developing World""; ""FINAL AGENDA""; ""Day 1""; ""Day 2""
""WORKSHOP SPEAKERS""""WORKSHOP PARTICIPANTS""; ""Staff""; ""Appendix B Involving the U.S. Public and Private Sectors in the CVI""; ""FINAL AGENDA""; ""Day 1""; ""Involving the U.S. Public and Private Sectors in the CVI""; ""WORKSHOP SPEAKERS""; ""COMMISSIONED PAPER""; ""WORKSHOP PARTICIPANTS""; ""Staff""; ""Appendix C Acronyms and Abbreviations""
Record Nr. UNINA-9910777424803321
Washington, D.C. : , : National Academy Press, , 1995
Materiale a stampa
Lo trovi qui: Univ. Federico II
Opac: Controlla la disponibilità qui
The children's vaccine initiative : continuing activities : a summary of two workshops held September 12-13 and October 25-26, 1994 / / Greg W. Pearson, editor ; Steering Committee on the Children's Vaccine Initiative: Continuing Activities, Division of Health Promotion and Disease Prevention, Institute of Medicine
The children's vaccine initiative : continuing activities : a summary of two workshops held September 12-13 and October 25-26, 1994 / / Greg W. Pearson, editor ; Steering Committee on the Children's Vaccine Initiative: Continuing Activities, Division of Health Promotion and Disease Prevention, Institute of Medicine
Edizione [1st ed.]
Pubbl/distr/stampa Washington, D.C. : , : National Academy Press, , 1995
Descrizione fisica 1 online resource (x, 55 pages)
Disciplina 614.47
Altri autori (Persone) PearsonGreg W
HallCaroline Breese
Soggetto topico Vaccination of children
Vaccines
Immunization of children
Formato Materiale a stampa
Livello bibliografico Monografia
Lingua di pubblicazione eng
Nota di contenuto ""The Children's Vaccine Initiative: Continuing Activities""; ""Copyright""; ""Preface""; ""Contents""; ""Promise and Problems: Hib, Pneumococcal, and Meningococcal Vaccines in the Developing World""; ""INTRODUCTION""; ""ARI AND MENINGOCOCCAL MENINGITIS IN THE DEVELOPING WORLD""; ""DETERMINING VACCINE NEED""; ""OVERCOMING SCIENTIFIC AND TECHNOLOGICAL BARRIERS""; ""Pneumococcal Vaccines""; ""Meningococcal Vaccines""; ""PROVING VACCINE EFFICACY: THE CHALLENGE OF DEVELOPING-COUNTRY FIELD TRIALS""; ""The Public-/Private-Sector Interface""; ""INTRODUCING AN EFFECTIVE VACCINE""
""Involving the U.S. Public and Private Sectors in the CVI""""INTRODUCTION""; ""BRINGING CLARITY TO THE CVI VISION""; ""TRENDS IN THE GLOBAL VACCINE SITUATION""; ""Industry Characteristics""; ""Local Production and Self-Sufficiency""; ""RESHAPING THE EPI""; ""A ROLE FOR INDUSTRY""; ""Barriers to Participation""; ""FACILITATING GREATER U.S. INVOLVEMENT""; ""Differential Pricing""; ""Technology Transfer""; ""DISCUSSION SUMMARY""; ""Appendix A Promise and Problems: Hib, Pneumococcal, and Meningococcal Vaccines in the Developing World""; ""FINAL AGENDA""; ""Day 1""; ""Day 2""
""WORKSHOP SPEAKERS""""WORKSHOP PARTICIPANTS""; ""Staff""; ""Appendix B Involving the U.S. Public and Private Sectors in the CVI""; ""FINAL AGENDA""; ""Day 1""; ""Involving the U.S. Public and Private Sectors in the CVI""; ""WORKSHOP SPEAKERS""; ""COMMISSIONED PAPER""; ""WORKSHOP PARTICIPANTS""; ""Staff""; ""Appendix C Acronyms and Abbreviations""
Record Nr. UNINA-9911087421503321
Washington, D.C. : , : National Academy Press, , 1995
Materiale a stampa
Lo trovi qui: Univ. Federico II
Opac: Controlla la disponibilità qui
The children's vaccine initiative : continuing activities : a summary of two workshops held September 12-13 and October 25-26, 1994 / / Greg W. Pearson, editor ; Steering Committee on the Children's Vaccine Initiative: Continuing Activities, Division of Health Promotion and Disease Prevention, Institute of Medicine
The children's vaccine initiative : continuing activities : a summary of two workshops held September 12-13 and October 25-26, 1994 / / Greg W. Pearson, editor ; Steering Committee on the Children's Vaccine Initiative: Continuing Activities, Division of Health Promotion and Disease Prevention, Institute of Medicine
Edizione [1st ed.]
Pubbl/distr/stampa Washington, D.C. : , : National Academy Press, , 1995
Descrizione fisica 1 online resource (x, 55 pages)
Disciplina 614.47
Altri autori (Persone) PearsonGreg W
HallCaroline Breese
Soggetto topico Vaccination of children
Vaccines
Immunization of children
Formato Materiale a stampa
Livello bibliografico Monografia
Lingua di pubblicazione eng
Nota di contenuto ""The Children's Vaccine Initiative: Continuing Activities""; ""Copyright""; ""Preface""; ""Contents""; ""Promise and Problems: Hib, Pneumococcal, and Meningococcal Vaccines in the Developing World""; ""INTRODUCTION""; ""ARI AND MENINGOCOCCAL MENINGITIS IN THE DEVELOPING WORLD""; ""DETERMINING VACCINE NEED""; ""OVERCOMING SCIENTIFIC AND TECHNOLOGICAL BARRIERS""; ""Pneumococcal Vaccines""; ""Meningococcal Vaccines""; ""PROVING VACCINE EFFICACY: THE CHALLENGE OF DEVELOPING-COUNTRY FIELD TRIALS""; ""The Public-/Private-Sector Interface""; ""INTRODUCING AN EFFECTIVE VACCINE""
""Involving the U.S. Public and Private Sectors in the CVI""""INTRODUCTION""; ""BRINGING CLARITY TO THE CVI VISION""; ""TRENDS IN THE GLOBAL VACCINE SITUATION""; ""Industry Characteristics""; ""Local Production and Self-Sufficiency""; ""RESHAPING THE EPI""; ""A ROLE FOR INDUSTRY""; ""Barriers to Participation""; ""FACILITATING GREATER U.S. INVOLVEMENT""; ""Differential Pricing""; ""Technology Transfer""; ""DISCUSSION SUMMARY""; ""Appendix A Promise and Problems: Hib, Pneumococcal, and Meningococcal Vaccines in the Developing World""; ""FINAL AGENDA""; ""Day 1""; ""Day 2""
""WORKSHOP SPEAKERS""""WORKSHOP PARTICIPANTS""; ""Staff""; ""Appendix B Involving the U.S. Public and Private Sectors in the CVI""; ""FINAL AGENDA""; ""Day 1""; ""Involving the U.S. Public and Private Sectors in the CVI""; ""WORKSHOP SPEAKERS""; ""COMMISSIONED PAPER""; ""WORKSHOP PARTICIPANTS""; ""Staff""; ""Appendix C Acronyms and Abbreviations""
Record Nr. UNINA-9911141473103321
Washington, D.C. : , : National Academy Press, , 1995
Materiale a stampa
Lo trovi qui: Univ. Federico II
Opac: Controlla la disponibilità qui
The children's vaccine initiative [[electronic resource] ] : achieving the vision / / Violaine S. Mitchell, Nalini M. Philipose, and Jay P. Sanford, editors ; Committee on the Children's Vaccine Initiative : Planning Alternative Strategies Toward Full U.S. Participation, Division of International Health, Institute of Medicine
The children's vaccine initiative [[electronic resource] ] : achieving the vision / / Violaine S. Mitchell, Nalini M. Philipose, and Jay P. Sanford, editors ; Committee on the Children's Vaccine Initiative : Planning Alternative Strategies Toward Full U.S. Participation, Division of International Health, Institute of Medicine
Pubbl/distr/stampa Washington, D.C., : National Academy Press, 1993
Descrizione fisica xiii, 221 p. : ill
Disciplina 614.4/7/083
Altri autori (Persone) SanfordJay P. <1928->
MitchellViolaine S
PhiliposeNalini M
Soggetto topico Vaccination of children
Vaccines
Immunization of children
Soggetto genere / forma Electronic books.
ISBN 1-280-19601-7
9786610196012
0-309-58583-X
0-585-14352-8
Formato Materiale a stampa
Livello bibliografico Monografia
Lingua di pubblicazione eng
Record Nr. UNINA-9910455898903321
Washington, D.C., : National Academy Press, 1993
Materiale a stampa
Lo trovi qui: Univ. Federico II
Opac: Controlla la disponibilità qui
The children's vaccine initiative : achieving the vision / / Violaine S. Mitchell, Nalini M. Philipose, and Jay P. Sanford, editors ; Committee on the Children's Vaccine Initiative : Planning Alternative Strategies Toward Full U.S. Participation, Division of International Health, Institute of Medicine
The children's vaccine initiative : achieving the vision / / Violaine S. Mitchell, Nalini M. Philipose, and Jay P. Sanford, editors ; Committee on the Children's Vaccine Initiative : Planning Alternative Strategies Toward Full U.S. Participation, Division of International Health, Institute of Medicine
Pubbl/distr/stampa Washington, D.C., : National Academy Press, 1993
Descrizione fisica 1 online resource (xiii, 221 pages) : illustrations
Disciplina 614.4/7/083
Altri autori (Persone) SanfordJay P. <1928->
MitchellViolaine S
PhiliposeNalini M
Soggetto topico Vaccination of children
Vaccines
Immunization of children
ISBN 1-280-19601-7
9786610196012
0-309-58583-X
0-585-14352-8
Formato Materiale a stampa
Livello bibliografico Monografia
Lingua di pubblicazione eng
Record Nr. UNINA-9910778792903321
Washington, D.C., : National Academy Press, 1993
Materiale a stampa
Lo trovi qui: Univ. Federico II
Opac: Controlla la disponibilità qui
The children's vaccine initiative : achieving the vision / / Violaine S. Mitchell, Nalini M. Philipose, and Jay P. Sanford, editors ; Committee on the Children's Vaccine Initiative : Planning Alternative Strategies Toward Full U.S. Participation, Division of International Health, Institute of Medicine
The children's vaccine initiative : achieving the vision / / Violaine S. Mitchell, Nalini M. Philipose, and Jay P. Sanford, editors ; Committee on the Children's Vaccine Initiative : Planning Alternative Strategies Toward Full U.S. Participation, Division of International Health, Institute of Medicine
Edizione [1st ed.]
Pubbl/distr/stampa Washington, D.C., : National Academy Press, 1993
Descrizione fisica 1 online resource (xiii, 221 pages) : illustrations
Disciplina 614.4/7/083
Altri autori (Persone) SanfordJay P. <1928->
MitchellViolaine S
PhiliposeNalini M
Soggetto topico Vaccination of children
Vaccines
Immunization of children
Vaccination
Children
Infants
Immunization Programs
Child
Immunization Schedule
Infant
ISBN 9786610196012
9781280196010
1280196017
9780309585835
030958583X
9780585143521
0585143528
Formato Materiale a stampa
Livello bibliografico Monografia
Lingua di pubblicazione eng
Nota di contenuto The Children's Vaccine Initiative -- Copyright -- Preface -- Acknowledgments -- Contents -- 1 Executive Summary -- THE CHILDREN'S VACCINE INITIATIVE -- THE INSTITUTE OF MEDICINE REPORT -- COMMITTEE FINDINGS -- Resources and Infrastructure -- Vaccine Demand and Supply -- Demand -- Supply -- Innovation -- Investing in New and Improved Vaccines -- Stages of Vaccine Development -- Pilot Production -- Clinical Trials -- Scaleup and Large-Scale Manufacture -- Technology Transfer -- A STRATEGY TO ENHANCE U.S. PARTICIPATION -- NOTE -- REFERENCE -- 2 Why a Children's Vaccine Initiative? -- PROGRESS TOWARD UNIVERSAL CHILDHOOD IMMUNIZATION -- Limits of the Expanded Program on Immunization -- THE CHILDREN'S VACCINE INITIATIVE -- Characteristics of CVI Vaccines -- Vaccines Should Be Single Dose -- Vaccines Should Be Administered Near Birth -- Vaccines Should Be Combined in Novel Ways -- Vaccines Should Be Heat Stable -- Vaccines Should Be Effective Against Additional Diseases -- Vaccines Should Be Affordable -- Concerns About the CVI -- RELEVANCE OF THE CVI TO U.S. IMMUNIZATION EFFORTS -- Status of Immunization Efforts in the United States -- A Role for the CVI in the United States -- REFERENCES -- 3 Resources and Infrastructure -- RESOURCES IN THE UNITED STATES -- U.S. Federal Agencies and Programs -- U.S. Agency for International Development -- Center for Biologics Evaluation and Research, U.S. Food and Drug Administration -- Centers for Disease Control and Prevention -- U.S. Department of Defense -- National Institutes of Health -- National Vaccine Program -- Other Federal Programs -- U.S. State Vaccine Manufacturers -- Massachusetts -- Michigan -- U.S.-Based Pharmaceutical Firms -- Connaught Laboratories, Inc. -- Lederle-Proxis Biologicals -- Merck & -- Co., Inc. -- SmithKline Beecham -- Wyeth-Ayerst -- Development-Stage Companies.
North American Vaccine -- MedImmune -- Univax Biologics, Inc. -- Nongovernmental Organizations -- The Children's Defense Fund -- March of Dimes Birth Defects Foundation -- Rockefeller Foundation -- Rotary Foundation -- INTERNATIONAL RESOURCES -- Multilateral Organizations -- Pan American Health Organization -- PAHO Revolving Fund -- SIREVA Project -- United Nations Development Program -- United Nations Children's Fund -- Vaccine Independence Initiative -- World Bank -- World Health Organization -- Expanded Program on Immunization -- Program for Vaccine Development -- Children's Vaccine Initiative -- Public-Sector Resources -- Private-Sector Resources -- Nongovernmental Organizations -- Task Force for Child Survival and Development -- Save the Children Fund -- REFERENCES -- 4 Vaccine Demand and Supply -- GLOBAL DEMAND AND SUPPLY -- Demand -- Regional Demand -- Supply -- Procurement -- Innovation -- DEMAND AND SUPPLY IN THE UNITED STATES -- Demand -- Supply -- Pricing -- Vaccine Innovation -- NOTE -- REFERENCES -- 5 Investing in New and Improved Vaccines -- MARKET CONSIDERATIONS -- Market Size -- Intellectual Property -- Patent Rights and Limitations -- Patents and Vaccines -- Infringement -- LIABILITY -- REFERENCES -- 6 Stages of Vaccine Development -- PRIORITY SETTING -- BASIC AND APPLIED RESEARCH -- CLINICAL EVALUATION -- LICENSURE -- PRODUCTION -- Pilot Production -- ScaleUp and Full-Scale Manufacture -- Vaccine Production in Developing Countries -- RECOMMENDATIONS FOR USE -- PROCUREMENT -- DISTRIBUTION AND DELIVERY -- SURVEILLANCE -- Immunization Status -- Monitoring Effectiveness of Vaccines -- Adverse Reactions -- Setting Priorities for Vaccine Use and New Vaccines -- REFERENCES -- 7 A Strategy to Enhance U.S. Participation in the Children's Vaccine Initiative -- A NATIONAL VACCINE AUTHORITY -- Mission -- Functions.
Setting Priorities and Product Characterization -- Basic Research -- Applied Research and Exploratory Development -- Intellectual Property Rights -- Product Development -- Clinical Evaluation -- Regulation -- Manufacture -- Procurement -- Monitoring and Evaluation -- Management and Organization -- Funding -- Location -- Points to Consider for Locating the CVI in an Existing Federal Agency -- Options -- U.S. Agency for International Development -- Centers for Disease Control and Prevention -- U.S. Department of Defense -- U.S. Food and Drug Administration -- National Institutes of Health -- The National Vaccine Program -- Independent Organization -- NOTE -- REFERENCES -- Appendixes -- A Relevant Intellectual Property Rights Law -- PATENTS -- Rights and Limitations -- Infringement -- Potential Barriers and Incentives -- First-to-File Versus First-to-Invent -- Backlog in the Patent and Trademark Office -- Costs -- Disclosure to Government Agencies -- Relevant Legislation and Terminology -- Drug Price Competition and Patent Term Restoration Act of 1984 (P.L. 98-417) -- Omnibus Trade and Competitiveness Act (P.L. 100-418) -- Grace Period -- Orphan Drug Act of 1983 (P.L. 99-91) -- Patent and Trademark Amendments of 1980 (P.L 96-517) -- Experimental Use Exception -- TRADE SECRETS (KNOW-HOW) -- Definition -- Confidentiality -- Rights of the Trade Secret Owner -- Rights Against Individuals in Privity -- Protection by Contract -- Implied Contract/Special Relationships -- Rights Against Third Parties -- Additional Rights of a Trade Secret Owner -- Rights to Use Another's Trade Secrets -- REFERENCES -- B National Vaccine Injury Compensation Program -- DEFINITION AND PURPOSE -- BACKGROUND -- FILING A CLAIM UNDER NVICP -- KEY CHARACTERISTICS -- REFERENCES -- C Regulatory Aspects of Vaccine Development, Manufacture, and Distribution -- THE LICENSURE PROCESS.
POSTLICENSING -- Manufacture -- Distribution -- THE DRUG EXPORT AMENDMENTS ACT OF 1986 -- REFERENCES -- D Strategies for Achieving Full U.S. Participation in the Children's Vaccine Initiative -- STRATEGY 1: RETAIN THE CURRENT SYSTEM -- Option 1: Increased Funding for CVI Vaccine Research -- Contribution to the Global CVI -- Option 2: Purchase Existing Vaccines -- Contribution to the Global CVI -- Option 3: Improve Vaccine Delivery -- Contribution to the Global CVI -- STRATEGY 2: FORGING NEW PARTNERSHIPS BETWEEN THE PUBLIC AND PRIVATE SECTORS -- Option 1: Broker CVI R& -- D and Pilot Manufacture -- Contribution to the Global CVI -- Option 2: Develop an Entity with CVI-Related R& -- D and Pilot Manufacturing Capabilities -- Contribution to the Global CVI -- STRATEGY 3: EMBARK ON A PUBLIC-SECTOR MODEL -- Contribution to the Global CVI -- E Public Health Service Act (1944) -- PUBLIC LAWS-CH. 373-JULY 1, 1944 PART F-BIOLOGICAL PRODUCTS Regulation of Biological Products -- Interference With Officers -- Penalties for Offenses -- F National Vaccine Program Legislation -- TITLE XXI-VACCINES SUBTITLE 1-NATIONAL VACCINE PROGRAM -- Establishment -- Program Responsibilities -- Plan -- Report -- National Vaccine Advisory Committee -- Authorizations -- G Immunization Schedules -- H Historical Record of Vaccine Product License Holders in the United States -- I Working Group Participants June 11-13, 1992 -- NOTES -- J Committee and Staff Biographies -- K Acronyms.
Record Nr. UNINA-9911102956203321
Washington, D.C., : National Academy Press, 1993
Materiale a stampa
Lo trovi qui: Univ. Federico II
Opac: Controlla la disponibilità qui
The children's vaccine initiative : achieving the vision / / Violaine S. Mitchell, Nalini M. Philipose, and Jay P. Sanford, editors ; Committee on the Children's Vaccine Initiative : Planning Alternative Strategies Toward Full U.S. Participation, Division of International Health, Institute of Medicine
The children's vaccine initiative : achieving the vision / / Violaine S. Mitchell, Nalini M. Philipose, and Jay P. Sanford, editors ; Committee on the Children's Vaccine Initiative : Planning Alternative Strategies Toward Full U.S. Participation, Division of International Health, Institute of Medicine
Edizione [1st ed.]
Pubbl/distr/stampa Washington, D.C., : National Academy Press, 1993
Descrizione fisica 1 online resource (xiii, 221 pages) : illustrations
Disciplina 614.4/7/083
Altri autori (Persone) SanfordJay P. <1928->
MitchellViolaine S
PhiliposeNalini M
Soggetto topico Vaccination of children
Vaccines
Immunization of children
Vaccination
Children
Infants
Immunization Programs
Child
Immunization Schedule
Infant
ISBN 9786610196012
9781280196010
1280196017
9780309585835
030958583X
9780585143521
0585143528
Formato Materiale a stampa
Livello bibliografico Monografia
Lingua di pubblicazione eng
Nota di contenuto The Children's Vaccine Initiative -- Copyright -- Preface -- Acknowledgments -- Contents -- 1 Executive Summary -- THE CHILDREN'S VACCINE INITIATIVE -- THE INSTITUTE OF MEDICINE REPORT -- COMMITTEE FINDINGS -- Resources and Infrastructure -- Vaccine Demand and Supply -- Demand -- Supply -- Innovation -- Investing in New and Improved Vaccines -- Stages of Vaccine Development -- Pilot Production -- Clinical Trials -- Scaleup and Large-Scale Manufacture -- Technology Transfer -- A STRATEGY TO ENHANCE U.S. PARTICIPATION -- NOTE -- REFERENCE -- 2 Why a Children's Vaccine Initiative? -- PROGRESS TOWARD UNIVERSAL CHILDHOOD IMMUNIZATION -- Limits of the Expanded Program on Immunization -- THE CHILDREN'S VACCINE INITIATIVE -- Characteristics of CVI Vaccines -- Vaccines Should Be Single Dose -- Vaccines Should Be Administered Near Birth -- Vaccines Should Be Combined in Novel Ways -- Vaccines Should Be Heat Stable -- Vaccines Should Be Effective Against Additional Diseases -- Vaccines Should Be Affordable -- Concerns About the CVI -- RELEVANCE OF THE CVI TO U.S. IMMUNIZATION EFFORTS -- Status of Immunization Efforts in the United States -- A Role for the CVI in the United States -- REFERENCES -- 3 Resources and Infrastructure -- RESOURCES IN THE UNITED STATES -- U.S. Federal Agencies and Programs -- U.S. Agency for International Development -- Center for Biologics Evaluation and Research, U.S. Food and Drug Administration -- Centers for Disease Control and Prevention -- U.S. Department of Defense -- National Institutes of Health -- National Vaccine Program -- Other Federal Programs -- U.S. State Vaccine Manufacturers -- Massachusetts -- Michigan -- U.S.-Based Pharmaceutical Firms -- Connaught Laboratories, Inc. -- Lederle-Proxis Biologicals -- Merck & -- Co., Inc. -- SmithKline Beecham -- Wyeth-Ayerst -- Development-Stage Companies.
North American Vaccine -- MedImmune -- Univax Biologics, Inc. -- Nongovernmental Organizations -- The Children's Defense Fund -- March of Dimes Birth Defects Foundation -- Rockefeller Foundation -- Rotary Foundation -- INTERNATIONAL RESOURCES -- Multilateral Organizations -- Pan American Health Organization -- PAHO Revolving Fund -- SIREVA Project -- United Nations Development Program -- United Nations Children's Fund -- Vaccine Independence Initiative -- World Bank -- World Health Organization -- Expanded Program on Immunization -- Program for Vaccine Development -- Children's Vaccine Initiative -- Public-Sector Resources -- Private-Sector Resources -- Nongovernmental Organizations -- Task Force for Child Survival and Development -- Save the Children Fund -- REFERENCES -- 4 Vaccine Demand and Supply -- GLOBAL DEMAND AND SUPPLY -- Demand -- Regional Demand -- Supply -- Procurement -- Innovation -- DEMAND AND SUPPLY IN THE UNITED STATES -- Demand -- Supply -- Pricing -- Vaccine Innovation -- NOTE -- REFERENCES -- 5 Investing in New and Improved Vaccines -- MARKET CONSIDERATIONS -- Market Size -- Intellectual Property -- Patent Rights and Limitations -- Patents and Vaccines -- Infringement -- LIABILITY -- REFERENCES -- 6 Stages of Vaccine Development -- PRIORITY SETTING -- BASIC AND APPLIED RESEARCH -- CLINICAL EVALUATION -- LICENSURE -- PRODUCTION -- Pilot Production -- ScaleUp and Full-Scale Manufacture -- Vaccine Production in Developing Countries -- RECOMMENDATIONS FOR USE -- PROCUREMENT -- DISTRIBUTION AND DELIVERY -- SURVEILLANCE -- Immunization Status -- Monitoring Effectiveness of Vaccines -- Adverse Reactions -- Setting Priorities for Vaccine Use and New Vaccines -- REFERENCES -- 7 A Strategy to Enhance U.S. Participation in the Children's Vaccine Initiative -- A NATIONAL VACCINE AUTHORITY -- Mission -- Functions.
Setting Priorities and Product Characterization -- Basic Research -- Applied Research and Exploratory Development -- Intellectual Property Rights -- Product Development -- Clinical Evaluation -- Regulation -- Manufacture -- Procurement -- Monitoring and Evaluation -- Management and Organization -- Funding -- Location -- Points to Consider for Locating the CVI in an Existing Federal Agency -- Options -- U.S. Agency for International Development -- Centers for Disease Control and Prevention -- U.S. Department of Defense -- U.S. Food and Drug Administration -- National Institutes of Health -- The National Vaccine Program -- Independent Organization -- NOTE -- REFERENCES -- Appendixes -- A Relevant Intellectual Property Rights Law -- PATENTS -- Rights and Limitations -- Infringement -- Potential Barriers and Incentives -- First-to-File Versus First-to-Invent -- Backlog in the Patent and Trademark Office -- Costs -- Disclosure to Government Agencies -- Relevant Legislation and Terminology -- Drug Price Competition and Patent Term Restoration Act of 1984 (P.L. 98-417) -- Omnibus Trade and Competitiveness Act (P.L. 100-418) -- Grace Period -- Orphan Drug Act of 1983 (P.L. 99-91) -- Patent and Trademark Amendments of 1980 (P.L 96-517) -- Experimental Use Exception -- TRADE SECRETS (KNOW-HOW) -- Definition -- Confidentiality -- Rights of the Trade Secret Owner -- Rights Against Individuals in Privity -- Protection by Contract -- Implied Contract/Special Relationships -- Rights Against Third Parties -- Additional Rights of a Trade Secret Owner -- Rights to Use Another's Trade Secrets -- REFERENCES -- B National Vaccine Injury Compensation Program -- DEFINITION AND PURPOSE -- BACKGROUND -- FILING A CLAIM UNDER NVICP -- KEY CHARACTERISTICS -- REFERENCES -- C Regulatory Aspects of Vaccine Development, Manufacture, and Distribution -- THE LICENSURE PROCESS.
POSTLICENSING -- Manufacture -- Distribution -- THE DRUG EXPORT AMENDMENTS ACT OF 1986 -- REFERENCES -- D Strategies for Achieving Full U.S. Participation in the Children's Vaccine Initiative -- STRATEGY 1: RETAIN THE CURRENT SYSTEM -- Option 1: Increased Funding for CVI Vaccine Research -- Contribution to the Global CVI -- Option 2: Purchase Existing Vaccines -- Contribution to the Global CVI -- Option 3: Improve Vaccine Delivery -- Contribution to the Global CVI -- STRATEGY 2: FORGING NEW PARTNERSHIPS BETWEEN THE PUBLIC AND PRIVATE SECTORS -- Option 1: Broker CVI R& -- D and Pilot Manufacture -- Contribution to the Global CVI -- Option 2: Develop an Entity with CVI-Related R& -- D and Pilot Manufacturing Capabilities -- Contribution to the Global CVI -- STRATEGY 3: EMBARK ON A PUBLIC-SECTOR MODEL -- Contribution to the Global CVI -- E Public Health Service Act (1944) -- PUBLIC LAWS-CH. 373-JULY 1, 1944 PART F-BIOLOGICAL PRODUCTS Regulation of Biological Products -- Interference With Officers -- Penalties for Offenses -- F National Vaccine Program Legislation -- TITLE XXI-VACCINES SUBTITLE 1-NATIONAL VACCINE PROGRAM -- Establishment -- Program Responsibilities -- Plan -- Report -- National Vaccine Advisory Committee -- Authorizations -- G Immunization Schedules -- H Historical Record of Vaccine Product License Holders in the United States -- I Working Group Participants June 11-13, 1992 -- NOTES -- J Committee and Staff Biographies -- K Acronyms.
Record Nr. UNINA-9911147234603321
Washington, D.C., : National Academy Press, 1993
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Compensating for provider nonresponse using response propensities to form adjustment cells : the National Immunization Survey : data from the National Health Care Survey / / Philip J. Smith [and five others]
Compensating for provider nonresponse using response propensities to form adjustment cells : the National Immunization Survey : data from the National Health Care Survey / / Philip J. Smith [and five others]
Pubbl/distr/stampa Hyattsville, Maryland : , : U.S. Department of Health and Human Services, Centers for Disease Control and Prevention, National Center for Health Statistics, , 2001
Descrizione fisica 1 online resource (iii, 17 pages) : one illustration
Collana Vital and health statistics. Series 2, Data evaluation and methods research
DHHS publication
Soggetto topico Immunization of children - United States
Health surveys - United States - Methodology
Medical care surveys - Response rate - United States
Health surveys - Methodology
Immunization of children
Formato Materiale a stampa
Livello bibliografico Monografia
Lingua di pubblicazione eng
Altri titoli varianti Compensating for provider nonresponse using response propensities to form adjustment cells
Record Nr. UNINA-9910712988503321
Hyattsville, Maryland : , : U.S. Department of Health and Human Services, Centers for Disease Control and Prevention, National Center for Health Statistics, , 2001
Materiale a stampa
Lo trovi qui: Univ. Federico II
Opac: Controlla la disponibilità qui