Download or read book Discussion Paper on Proposed Packaging Guidelines for Shipment of Vaccines written by and published by . This book was released on 1979 with total page pages. Available in PDF, EPUB and Kindle. Book excerpt:
Download or read book Guidelines for the international packaging and shipping of vaccines written by and published by World Health Organization. This book was released on 2020-12-22 with total page 169 pages. Available in PDF, EPUB and Kindle. Book excerpt: International shipping of vaccines is the first leg of the complex journey that vaccines undertake to reach the end users in a country. Particular challenges include the size and weight of packages, implementation of quality control checks at reception, ensuring environmental sustainability, and maintaining required temperatures during the journey. Although there are many possibilities of transport e.g. sea freight and terrestrial transportation, air freight currently remains the most widely used means of transport for vaccines. In recognition of this fact, these guidelines apply predominantly to the air freighting of vaccines. Transportation of vaccines from the manufacturing facility to the airport facility require the use of ground transportation, and reference is also made to the qualification of refrigerated road vehicles as well. The objective of these guidelines is to provide technical guidance to help ensure the quality of vaccines during all stages of the international air transportation process. These guidelines are applicable to all persons and institutions involved in international air shipment of vaccines from the premises of the product manufacturer to the recipient country. This includes all parties involved in shipment, vaccine manufacturers, logistics service providers (LSPs), freight forwarders, carriers and their employees. The relevant sections of these guidelines should also be considered for implementation by UN procurement agencies and other international procurement organizations, countries, donor agencies and certifying bodies.
Download or read book Guidelines on the International Packaging and Shipping of Vaccines written by and published by . This book was released on 1992 with total page 2 pages. Available in PDF, EPUB and Kindle. Book excerpt:
Download or read book FDA s Drug Review Process and the Package Label written by Tom Brody and published by Academic Press. This book was released on 2017-12-01 with total page 671 pages. Available in PDF, EPUB and Kindle. Book excerpt: FDA's Drug Review Process and the Package Label provides guidance to pharmaceutical companies for writing FDA-submissions, such as the NDA, BLA, Clinical Study Reports, and Investigator's Brochures. The book provides guidance to medical writers for drafting FDA-submissions in a way more likely to persuade FDA reviewers to grant approval of the drug. In detail, the book reproduces data on efficacy and safety from one hundred different FDA-submissions (NDAs, BLAs). The book reproduces comments and complaints from FDA reviewers regarding data that are fragmentary, ambiguous, or that detract from the drug's approvability, and the book reveals how sponsors overcame FDA's concerns and how sponsors succeeded in persuading FDA to grant approval of the drug. The book uses the most reliable and comprehensive source of information available for writing FDA-submissions, namely text and data from NDAs and BLAs, as published on FDA's website. The source material for writing this book included about 80,000 pages from FDA's Medical Reviews, FDA's Clinical Pharmacology Reviews, and FDA's Pharmacology Reviews, from one hundred different NDAs or BLAs for one hundred different drugs. Each chapter focuses on a different section of the package label, e.g., the Dosage and Administration section or the Drug Interactions section, and demonstrates how the sponsor's data supported that section of the package label. - Reveals strategies for winning FDA approval and for drafting the package label - Examples are from one hundred FDA-submissions (NDAs, BLAs) for one hundred different drugs, e.g., for oncology, metabolic diseases, autoimmune diseases, and neurological diseases - This book uses the most reliable and comprehensive source of information available for writing FDA-submissions, namely, the data from NDAs and BLAs as published on FDA's website at the time FDA grants approval to the drug
Download or read book Guidelines for Smallpox Vaccine Packing Shipping written by and published by . This book was released on 2007* with total page pages. Available in PDF, EPUB and Kindle. Book excerpt: The National Immunization Program of the Centers for Disease Control and Prevention has prepared the following guidelines for smallpox vaccine packing and shipping. These guidelines are based in part on CDC's research on different shipping and handling methods under strenuous test conditions. These guidelines are not intended to be rules and regulations. They are suggestions written primarily for personnel who pack and ship vaccines.
Download or read book Epidemiology and Prevention of Vaccine Preventable Diseases 13th Edition E Book written by Jennifer Hamborsky, MPH, MCHES and published by Public Health Foundation. This book was released on 2015-10-19 with total page 738 pages. Available in PDF, EPUB and Kindle. Book excerpt: The Public Health Foundation (PHF) in partnership with the Centers for Disease Control and Prevention (CDC) is pleased to announce the availability of Epidemiology and Prevention of Vaccine-Preventable Diseases, 13th Edition or “The Pink Book” E-Book. This resource provides the most current, comprehensive, and credible information on vaccine-preventable diseases, and contains updated content on immunization and vaccine information for public health practitioners, healthcare providers, health educators, pharmacists, nurses, and others involved in administering vaccines. “The Pink Book E-Book” allows you, your staff, and others to have quick access to features such as keyword search and chapter links. Online schedules and sources can also be accessed directly through e-readers with internet access. Current, credible, and comprehensive, “The Pink Book E-Book” contains information on each vaccine-preventable disease and delivers immunization providers with the latest information on: Principles of vaccination General recommendations on immunization Vaccine safety Child/adult immunization schedules International vaccines/Foreign language terms Vaccination data and statistics The E-Book format contains all of the information and updates that are in the print version, including: · New vaccine administration chapter · New recommendations regarding selection of storage units and temperature monitoring tools · New recommendations for vaccine transport · Updated information on available influenza vaccine products · Use of Tdap in pregnancy · Use of Tdap in persons 65 years of age or older · Use of PCV13 and PPSV23 in adults with immunocompromising conditions · New licensure information for varicella-zoster immune globulin Contact [email protected] for more information. For more news and specials on immunization and vaccines visit the Pink Book's Facebook fan page
Download or read book Report written by Kansas State Board of Health and published by . This book was released on 1920 with total page 834 pages. Available in PDF, EPUB and Kindle. Book excerpt:
Download or read book Report of the WHO Pandemic Vaccine Deployment Workshop Lagos Nigeria 4 6 November 2019 written by and published by World Health Organization. This book was released on 2020-12-21 with total page 27 pages. Available in PDF, EPUB and Kindle. Book excerpt: The Pandemic Vaccine Deployment Workshop held from 4 to 6 November 2019 in Lagos, Nigeria, brought together participants from several sectors that play a key role in deployment and vaccination operations. The aim of the workshop was to initiate the development of Nigeria’s National Deployment and Vaccination Plan for Pandemic Influenza Vaccines (NDVP). The interactive format of the workshop included a combination of presentations with the use of PIP Deploy.
Download or read book CDC Yellow Book 2018 Health Information for International Travel written by Centers for Disease Control and Prevention CDC and published by Oxford University Press. This book was released on 2017-04-17 with total page 705 pages. Available in PDF, EPUB and Kindle. Book excerpt: THE ESSENTIAL WORK IN TRAVEL MEDICINE -- NOW COMPLETELY UPDATED FOR 2018 As unprecedented numbers of travelers cross international borders each day, the need for up-to-date, practical information about the health challenges posed by travel has never been greater. For both international travelers and the health professionals who care for them, the CDC Yellow Book 2018: Health Information for International Travel is the definitive guide to staying safe and healthy anywhere in the world. The fully revised and updated 2018 edition codifies the U.S. government's most current health guidelines and information for international travelers, including pretravel vaccine recommendations, destination-specific health advice, and easy-to-reference maps, tables, and charts. The 2018 Yellow Book also addresses the needs of specific types of travelers, with dedicated sections on: · Precautions for pregnant travelers, immunocompromised travelers, and travelers with disabilities · Special considerations for newly arrived adoptees, immigrants, and refugees · Practical tips for last-minute or resource-limited travelers · Advice for air crews, humanitarian workers, missionaries, and others who provide care and support overseas Authored by a team of the world's most esteemed travel medicine experts, the Yellow Book is an essential resource for travelers -- and the clinicians overseeing their care -- at home and abroad.
Download or read book Making Markets for Vaccines written by Owen Barder and published by . This book was released on 2005 with total page 132 pages. Available in PDF, EPUB and Kindle. Book excerpt: A legacy of our generation -- Ch. 1. We need to invest more in vaccines -- Ch. 2. Promoting private investment in vaccine development -- Ch. 3. A market not a prize -- Ch. 4. Design choices -- Ch. 5. $3 billion per disease -- Ch. 6. Meeting industry requirements -- Ch. 7. How sponsors can do it.
Download or read book Immunization in Practice written by and published by World Health Organization. This book was released on 2015 with total page 292 pages. Available in PDF, EPUB and Kindle. Book excerpt: This practical guide contains seven modules targeted at district and health facility staff. It intends to meet the demands to improve immunization services so as to reach more infants in a sustainable way, building upon the experiences of polio eradication. It includes materials adapted from polio on planning, monitoring and use of data to improve the service, that can be used at any level. Revising the manual has been a team exercise. There are contributions from a large number of experts, organizations and institutions. This new edition has seven modules. Several new vaccines that have become more readily available and used in recent years have been added. Also the section on integration with other health interventions has been expanded as exciting opportunities and experiences have become evident in the years following the previous edition. Module 1: Target diseases and vaccines Module 2: The vaccine cold chain Module 3: Ensuring safe injections Module 4: Microplanning for reaching every community Module 5: Managing an immunization session Module 6: Monitoring and surveillance Module 7: Partnering with communities.
Download or read book Report of the meeting with industry to discuss common activities for deployment of pandemic influenza response products written by and published by World Health Organization. This book was released on 2020-12-21 with total page 30 pages. Available in PDF, EPUB and Kindle. Book excerpt: Preparedness and readiness for responding to a global pandemic influenza requires the engagement of many stakeholders. To ensure the effective and efficient allocation and deployment of pandemic influenza products to the populations most in need, manufacturers of such products play a critical role in the entire supply chain. Under the auspices of the Pandemic Influenza Preparedness Framework, the World Health Organization (WHO) organized two consultations with relevant industry representatives. The meetings provided an opportunity to exchange information on existing preparedness activities, to review challenges for pandemic vaccine production and deployment pathways and to identify areas where WHO and industry partners need to work together, including in the planning of future simulation exercises involving industry.
Download or read book Morbidity and Mortality Weekly Report written by and published by . This book was released on 2000 with total page 776 pages. Available in PDF, EPUB and Kindle. Book excerpt:
Download or read book Report of the Defense Science Board Task Force on Smallpox Vaccine Down Select Process report summary written by and published by DIANE Publishing. This book was released on 2004 with total page 28 pages. Available in PDF, EPUB and Kindle. Book excerpt: In the 17th century, physicians in China blew powdered smallpox scabs into sinuses and prepared pills made from the fleas of cows. In India, physicians applied scabs to the scarified skin of the healthy. This technique migrated westward to Turkey where it was discovered by western physicians. Other early attempts to control smallpox included inoculation with material from smallpox lesions. This practice was known as variolation. In 1796, Edward Jenner noted that milkmaids were free of the facial scars that marked most of the population of that time. The observation that they "cannot take smallpox" was attributed to the localized pox lesions that they developed in their hands. Jenner reasoned that infectious material from cowpox (caused by the vaccinia virus) lesions provided protection from smallpox (caused by the variola virus). He used it to vaccinate an 8-year-old boy. The boy later resisted infection, demonstrating the efficacy of the first vaccine.
Download or read book The Challenge of CMC Regulatory Compliance for Biopharmaceuticals written by John Geigert and published by Springer Nature. This book was released on 2023-06-15 with total page 597 pages. Available in PDF, EPUB and Kindle. Book excerpt: Each year for the past three years, there have been about 50 new molecular medicines approved by the United States Food & Drug Administration (FDA), of which approximately 25% were new biopharmaceuticals. Over 200 recombinant proteins, monoclonal antibodies, antibody drug conjugates, fusion proteins, and Fab fragments are now in the marketplace in both the United States of America (USA) and European Union (EU). There are also now over 60 biosimilars available for all major classes of recombinant proteins and monoclonal antibodies. In addition, gene therapies using genetically engineered viruses and genetically engineered cells are now in the marketplace, and continually growing. This degree of change is reflected in the over 400 CMC regulatory compliance references listed in this book that were either issued or updated since the release of the third edition. Deficiencies in biopharmaceutical CMC regulatory compliance rarely result in termination of a product, but in can readily cause months if not years of delay in initiating clinical trials, or advancing clinical development stages, or even market approval. In summary, this book: Updates real-world CMC deficiency examples with current examples; Addresses current FDA and EMA requirements and expectations for CMC regulatory compliance; Now includes CMC regulatory compliance for the new gene-based biopharmaceuticals.
Download or read book Report written by United States. Congress. House and published by . This book was released on with total page pages. Available in PDF, EPUB and Kindle. Book excerpt:
Download or read book Immunization Update written by and published by . This book was released on 1996 with total page 322 pages. Available in PDF, EPUB and Kindle. Book excerpt:
