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Author: Wija Oortwijn
Publisher: Radboud University Press
ISBN: 9083178951
Category : Technology & Engineering
Languages : en
Pages : 173
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Book Description
Health Technology Assessment (HTA) is defined as a multidisciplinary process that uses explicit methods to determine the value of a health technology at different points in its lifecycle. The purpose is to inform decision-making in order to promote an equitable, efficient, and high-quality health system. The definition reflects that facts and values are intertwined in HTA. This means that HTA should be considered as a type of policy analysis, wherein the assessment of safety, clinical and cost implications of health technologies, as well as their wider ethical, legal, social, organizational, environmental and other implications is conducted from the view that these aspects are closely interrelated, and wherein stakeholders are involved in a more productive way throughout the process of HTA. Acknowledging this holds the potential of conducting assessments of health technologies in a way that supports deliberative democratic decision making. In the 2018-2021 EU Erasmus+ strategic partnerships project “VALues In Doing Assessments ofhealthcare TEchnologies” (VALIDATE), a consortium of seven academic and HTA organizations have developed an approach to HTA that allows for the integration of empirical analysis and normative inquiry. The VALIDATE handbook: an approach on the integration of values in doing assessments of health technologies offers the reader an opportunity to get acquainted with the theoretical considerations and apprehend the associated practical and organizational implications of this approach. It offers those interested in HTA to integrate empirical analysis and normative inquiry in a transparent way.
Author: Wija Oortwijn
Publisher: Radboud University Press
ISBN: 9083178951
Category : Technology & Engineering
Languages : en
Pages : 173
Get Book Here
Book Description
Health Technology Assessment (HTA) is defined as a multidisciplinary process that uses explicit methods to determine the value of a health technology at different points in its lifecycle. The purpose is to inform decision-making in order to promote an equitable, efficient, and high-quality health system. The definition reflects that facts and values are intertwined in HTA. This means that HTA should be considered as a type of policy analysis, wherein the assessment of safety, clinical and cost implications of health technologies, as well as their wider ethical, legal, social, organizational, environmental and other implications is conducted from the view that these aspects are closely interrelated, and wherein stakeholders are involved in a more productive way throughout the process of HTA. Acknowledging this holds the potential of conducting assessments of health technologies in a way that supports deliberative democratic decision making. In the 2018-2021 EU Erasmus+ strategic partnerships project “VALues In Doing Assessments ofhealthcare TEchnologies” (VALIDATE), a consortium of seven academic and HTA organizations have developed an approach to HTA that allows for the integration of empirical analysis and normative inquiry. The VALIDATE handbook: an approach on the integration of values in doing assessments of health technologies offers the reader an opportunity to get acquainted with the theoretical considerations and apprehend the associated practical and organizational implications of this approach. It offers those interested in HTA to integrate empirical analysis and normative inquiry in a transparent way.
Author: James Agalloco
Publisher: CRC Press
ISBN: 1000436012
Category : Medical
Languages : en
Pages : 1062
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Book Description
Revised to reflect significant advances in pharmaceutical production and regulatory expectations, Handbook of Validation in Pharmaceutical Processes, Fourth Edition examines and blueprints every step of the validation process needed to remain compliant and competitive. This book blends the use of theoretical knowledge with recent technological advancements to achieve applied practical solutions. As the industry's leading source for validation of sterile pharmaceutical processes for more than 10 years, this greatly expanded work is a comprehensive analysis of all the fundamental elements of pharmaceutical and bio-pharmaceutical production processes. Handbook of Validation in Pharmaceutical Processes, Fourth Edition is essential for all global health care manufacturers and pharmaceutical industry professionals. Key Features: Provides an in-depth discussion of recent advances in sterilization Identifies obstacles that may be encountered at any stage of the validation program, and suggests the newest and most advanced solutions Explores distinctive and specific process steps, and identifies critical process control points to reach acceptable results New chapters include disposable systems, combination products, nano-technology, rapid microbial methods, contamination control in non-sterile products, liquid chemical sterilization, and medical device manufacture
Author: Michael E. Swartz
Publisher: CRC Press
ISBN: 142001448X
Category : Medical
Languages : en
Pages : 218
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Book Description
Written for practitioners in both the drug and biotechnology industries, this handbook carefully compiles the current regulatory requirements to correctly and properly validate a new or modified analytical method. The Handbook of Analytical Validation is designed to teach readers how to fully and correctly adapt new or modified analytical methods to meet regulatory requirements. The contents offer the latest regulatory requirements for submitting applications for new drugs or other applications, as regards analytical method validation. The chapters apply to both small molecules in the conventional pharmaceutical industry, as well the biotech industry.
Author: Stephen Robert Goldman
Publisher: 1st Book Library
ISBN:
Category : Business & Economics
Languages : en
Pages : 480
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Book Description
This handbook details methods for sustainable compliance with GxPs and 21 CFR Part 11 validation requirements regarding computerized systems in the pharmaceutical, biotechnology, and medical device industry. The handbook follows FDA guidelines and best industry practices in defining roles, responsib
Author: S. Scandizzo
Publisher: Springer
ISBN: 1137436964
Category : Business & Economics
Languages : en
Pages : 242
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Book Description
This book is a one-stop-shop reference for risk management practitioners involved in the validation of risk models. It is a comprehensive manual about the tools, techniques and processes to be followed, focused on all the models that are relevant in the capital requirements and supervisory review of large international banks.
Author: Robert Packard
Publisher:
ISBN: 9780967311524
Category :
Languages : en
Pages : 258
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Book Description
Reference text on validation processes for manufacturing medical devices.
Author: Anne Booth
Publisher: CRC Press
ISBN: 9781587160578
Category : Medical
Languages : en
Pages : 170
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Book Description
The validation and radiation sterilization process for biomaterials and medical devices requires careful planning to ensure regulatory compliance followed by precise accuracy in execution and documentation. This in-depth guide details all steps from prevalidation planning to final report and ongoing monitoring and control. Sterilization Validation & Routine Operation Handbook: Radiation provides a framework for the validation and routine operation of an irradiation sterilization process. The guidance presented complies with ANSI/AAMI/ISO 11137: 1994, Sterilization of health care product-Requirements for validation and routine control-Radiation sterilization and the newly published AAMI substantiation of 25 kGy using VDmax procedure. The author discusses methods to aid in comprehending the requirements in these standards. She also provides practical procedures for the validation and routine monitoring and control of specific gamma and electron beam radiation sterilization processes. Background chapters provide needed information on radiation sterilization technologies, sterilization microbiology, validation approaches and working with a radiation sterilization contractor. Much of the information in this new book is presented in convenient tables and charts, with diagrams and other schematics that simply illustrate appropriate validation methodologies. Sterilization Validation & Routine Operation Handbook: Radiation brings together in one resource information scattered throughout many documents and will be useful to all those involved in the sterilization of medical materials, drugs and devices.
Author: Craig Silverman
Publisher:
ISBN: 9781312023130
Category : Attribution of news
Languages : en
Pages : 120
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Book Description
Author: Jerry Banks
Publisher: John Wiley & Sons
ISBN: 9780471134039
Category : Technology & Engineering
Languages : en
Pages : 868
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Book Description
Dieses Buch ist eine unschätzbare Informationsquelle für alle Ingenieure, Designer, Manager und Techniker bei Entwicklung, Studium und Anwendung einer großen Vielzahl von Simulationstechniken. Es vereint die Arbeit internationaler Simulationsexperten aus Industrie und Forschung. Alle Aspekte der Simulation werden in diesem umfangreichen Nachschlagewerk abgedeckt. Der Leser wird vertraut gemacht mit den verschiedenen Techniken von Industriesimulationen sowie mit Einsatz, Anwendungen und Entwicklungen. Neueste Fortschritte wie z.B. objektorientierte Programmierung werden ebenso behandelt wie Richtlinien für den erfolgreichen Umgang mit simulationsgestützten Prozessen. Auch gibt es eine Liste mit den wichtigsten Vertriebs- und Zulieferadressen. (10/98)
Author: Gunter Jagschies
Publisher: Elsevier
ISBN: 0080554512
Category : Technology & Engineering
Languages : en
Pages : 383
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Book Description
This book will update the original edition published in 1997. Since the publication of the first edition, the biotechnology and biologics industries have gained extensive knowledge and experience in downstream processing using chromatography and other technologies associated with recovery and purification unit operations. This book will tie that experience together for the next generation of readers.Updates include:- sources and productivity- types of products made today- experiences in clinical and licensed products - economics- current status of validation- illustrations and tables- automated column packing- automated systemsNew topics include:- the use of disposables- multiproduct versus dedicated production- design principles for chromatography media and filters- ultrafiltration principles and optimization- risk assessments- characterization studies- design space- platform technologies- process analytical technologies (PATs)- biogenerics - comparability assessmentsKey Features:- new approaches to process optimiaztion- use of patform technologies- applying risk assessment to process design
