Enhancing compliance to good manufacturing practices and pharmaceutical quality system requirements in vaccine production PDF Download
Are you looking for read ebook online? Search for your book and save it on your Kindle device, PC, phones or tablets. Download Enhancing compliance to good manufacturing practices and pharmaceutical quality system requirements in vaccine production PDF full book. Access full book title Enhancing compliance to good manufacturing practices and pharmaceutical quality system requirements in vaccine production by World Health Organization. Download full books in PDF and EPUB format.
Author: World Health Organization
Publisher: World Health Organization
ISBN: 9240096019
Category : Medical
Languages : en
Pages : 72
Get Book Here
Book Description
Author: World Health Organization
Publisher: World Health Organization
ISBN: 9240096019
Category : Medical
Languages : en
Pages : 72
Get Book Here
Book Description
Author: Ciro A. de Quadros
Publisher: Pan American Health Org
ISBN: 9275115966
Category : Medical
Languages : en
Pages : 410
Get Book Here
Book Description
This publication contains a number of papers which consider the public health role of vaccines in improving the health of the world's populations, and looks at the challenges of using immunisation to combat emerging and re-emerging diseases. Issues discussed include the innovative use of vaccines against diseases such as meningococcal infection in Africa, Haemophilus influenza type b, varicella, and hepatitis, efforts to develop a new generation of vaccines against cholera and typhoid, shigella and Helicobacter pylori, as well as developments in the quest for vaccines against tuberculosis, HIV/AIDS, dengue, malaria, and hookworm. It also deals with the use of vaccines to fight bioterrorism attacks; regulatory and safety issues; financing issues, impact of health sector reform and the sustainability of immunisation programmes.
Author:
Publisher:
ISBN:
Category : Medical instruments and apparatus industry
Languages : en
Pages : 32
Get Book Here
Book Description
Author: JAMES. VESPER
Publisher:
ISBN: 9781942911289
Category :
Languages : en
Pages :
Get Book Here
Book Description
Author: National Academies of Sciences, Engineering, and Medicine
Publisher: National Academies Press
ISBN: 0309487811
Category : Medical
Languages : en
Pages : 69
Get Book Here
Book Description
On July 30-31, 2018, the National Academies of Sciences, Engineering, and Medicine held a workshop titled Continuous Manufacturing for the Modernization of Pharmaceutical Production. This workshop discussed the business and regulatory concerns associated with adopting continuous manufacturing techniques to produce biologics such as enzymes, monoclonal antibodies, and vaccines. The participants also discussed specific challenges for integration across the manufacturing system, including upstream and downstream processes, analytical techniques, and drug product development. The workshop addressed these challenges broadly across the biologics domain but focused particularly on drug categories of greatest FDA and industrial interest such as monoclonal antibodies and vaccines. This publication summarizes the presentations and discussions from the workshop.
Author:
Publisher: The Business Year
ISBN: 1912498812
Category : Business & Economics
Languages : en
Pages : 188
Get Book Here
Book Description
Colombia is undergoing a period of generation-marking adversity. And saying this of Colombia is a tall order given a tumultuous yesterday of armed conflict and internal mass displacement. Today's struggles are of a different nature, however. President Duque has had to give simultaneous management to the COVID-19 health crisis, the Venezuelan refugee crisis, and an expanding fiscal deficit situation that lost the country its investment-grade rating. All this against a backdrop of mass social discontent manifested by record-setting civilian protest. Considering this concoction of challenges, Colombian business leaders have demonstrated the exceptional traits of resilience that characterize this country's people. This edition of The Business Year: Colombia is dedicated to them. This 188-page publication aims to paint a picture of Colombia's current economic condition, examining each major sector through exclusive interviews, as well as news and analysis, from from finance to energy and transport to tourism.
Author: World Health Organization
Publisher: World Health Organization
ISBN: 9240092765
Category : Business & Economics
Languages : en
Pages : 84
Get Book Here
Book Description
The Local Production and Assistance (LPA) Unit in the Regulation and Prequalification Department (RPQ), Access to Medicines and Health Products Division (MHP), WHO, supports Member States (MS), particularly low- and middle-income countries (LMICs), to strengthen sustainable local production and technology transfer to improve timely, equitable access to quality, safe and effective essential medical products. The LPA Unit provides assistance and support to MS with an ecosystem-wide and holistic approach, such as fostering global coordination and partnerships, conducting ecosystem assessments for sustainable, quality local production, developing and implementing strategies/roadmaps, providing comprehensive capacity building and technical assistance, including for WHO Prequalification (PQ)/Emergency Use Listing (EUL), facilitating technology transfer (TT) and developing global resources on local production and TT. A landmark resolution WHA74.6 on strengthening local production of medicines and other health technologies to improve access was adopted in the Seventy-fourth World Health Assembly, signalling globally the important role local production plays in improving access and strengthening health security. Within this mandate, the LPA Unit, developed a series of case studies on the ecosystem for local production of pharmaceuticals, vaccines and biologicals, with a focus on country context in the low-and middle-income countries. These case studies add to the existing repository of resources on strengthening local production and technology transfer of health products for countries to leverage upon when countries embark in these areas. The countries in this series are Bangladesh, Kenya, Nigeria, Pakistan, Senegal and Tunisia. From July to September 2022, a series of interviews and consultative meetings, including a review of available literature, policies and other documents, and administration of a questionnaire, were performed. This case study is intended to report the collated information in areas such as available policies, initiatives, financing, regulatory system, patent protection system, research and development work, markets and capacity and preparedness to uptake local production of quality-assured pharmaceuticals, vaccines (including mRNA vaccines), and biologicals. The expectations and needs of these countries were also collected and included in the case study, along with proposed recommendations, for the reader to see various viewpoints towards strengthening sustainable local production and achieving universal health coverage and the Sustainable Development Goals.
Author: Sharyar Ahmed
Publisher: GRIN Verlag
ISBN: 3346248240
Category : Science
Languages : en
Pages : 43
Get Book Here
Book Description
Bachelor Thesis from the year 2017 in the subject Chemistry - Bio-chemistry, grade: 80.0, University of Birmingham (Engineering), course: Chemical Engineering, language: English, abstract: This paper covers a detail design and cost (to an accuracy of +/- 20 percent) for a new manufacturing facility to produce DNA vaccines to be built on a greenfield site. Applied current good manufacturing practice (cGMP) and complied with all the regulatory guidelines set up by various agencies. The demand for DNA vaccines in large quantities at high purity for gene therapy is on the increase. As it helps to stimulate antibodies production in human and provide immune protection against many diseases such as cancer, malaria, HIV and other diseases and have potential advantages over conventional vaccines.
Author: Elizabeth B. Andrews
Publisher: John Wiley & Sons
ISBN: 1118820142
Category : Medical
Languages : en
Pages : 878
Get Book Here
Book Description
Highly Commended at the BMA Medical Book Awards 2015 Mann’s Pharmacovigilance is the definitive reference for the science of detection, assessment, understanding and prevention of the adverse effects of medicines, including vaccines and biologics. Pharmacovigilance is increasingly important in improving drug safety for patients and reducing risk within the practice of pharmaceutical medicine. This new third edition covers the regulatory basis and the practice of pharmacovigilance and spontaneous adverse event reporting throughout the world. It examines signal detection and analysis, including the use of population-based databases and pharmacoepidemiological methodologies to proactively monitor for and assess safety signals. It includes chapters on drug safety practice in specific organ classes, special populations and special products, and new developments in the field. From an international team of expert editors and contributors, Mann’s Pharmacovigilance is a reference for everyone working within pharmaceutical companies, contract research organisations and medicine regulatory agencies, and for all researchers and students of pharmaceutical medicine. The book has been renamed in honor of Professor Ronald Mann, whose vision and leadership brought the first two editions into being, and who dedicated his long career to improving the safety and safe use of medicines.
Author: World Intellectual Property Organization
Publisher: WIPO
ISBN: 9280531743
Category : Law
Languages : en
Pages : 352
Get Book Here
Book Description
This study seeks to reinforce the understanding of the interplay between the distinct policy domains of health, trade and intellectual property, and of how they affect medical innovation and access to medical technologies. The second edition comprehensively reviews new developments in key areas since the initial launch of the study in 2013.
