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Feasibility Study Of An Active Substance Based Review System Monographs And Other Potential Alternatives For The Environmental Risk Assessment Of Veterinary Medicinal Products
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Book Synopsis Feasibility Study of an Active-substance-based Review System ('monographs') and Other Potential Alternatives for the Environmental Risk Assessment of Veterinary Medicinal Products by :
Download or read book Feasibility Study of an Active-substance-based Review System ('monographs') and Other Potential Alternatives for the Environmental Risk Assessment of Veterinary Medicinal Products written by and published by . This book was released on 2021 with total page pages. Available in PDF, EPUB and Kindle. Book excerpt: The objective of the present study was to assess the feasibility of an active-substance-based approach ("monograph system") and that of other potential alternatives for environmental risk assessment of veterinary medicinal products. The "monograph system" and two alternatives were examined with regard to their possible impacts as well as their efficiency and effectiveness in achieving the objectives of the VMPR: reduce the administrative burden, enhance the internal market, increase the availability of VMPs, while guaranteeing the highest level of public and animal health and protection of the environment. The outcome of this feasibility study shall assist the Commission in preparing a report to the European Parliament and Council examining the appropriateness and practicability of moving to a substance-based review system (instead of the current product-oriented review system) and proposing options for further policy action.
Book Synopsis Feasibility Study of an Active-substance-based Review System ('monographs') and Other Potential Alternatives for the Environmental Risk Assessment of Veterinary Medicinal Products by :
Download or read book Feasibility Study of an Active-substance-based Review System ('monographs') and Other Potential Alternatives for the Environmental Risk Assessment of Veterinary Medicinal Products written by and published by . This book was released on 2021 with total page pages. Available in PDF, EPUB and Kindle. Book excerpt: Both scientific and policy discussions have been ongoing for several years on the shortcomings of the current product-based environmental risk assessment of veterinary medicinal products in the EU, and the nature of potential alternatives. The present study identified, collected and analysed information to assess the feasibility of an active-substance-based approach ('monograph system') and other potential alternatives. The monograph system as defined in the literature, and two alternatives presented by Animal Health Europe and the European Group for Generic Veterinary Products were examined for their possible impacts, efficiency and effectiveness in achieving the objectives of Regulation (EU) 2019/06, i.e. reduce the administrative burden, enhance the internal market, increase the availability of VMPs, while guaranteeing the highest level of public and animal health and protection of the environment. In an initial phase the monograph system would be more expensive and resource-intensive, but in the long-term the benefits should overbalance the disadvantages. In addition, a number of suggestions were developed to improve the acceptability of the monograph system. The benefit would be enhanced by using existing tools and experiences from other regulatory frameworks. Moreover, it would support current EU strategic approaches, such as the "one substance, one assessment" approach of the European Green Deal (COM/2019/640). Especially in view of these EU goals, a monograph system is justified, proportionate and may be affordable in a long-time perspective.
Book Synopsis Veterinary Herbal Medicine by : Susan G. Wynn
Download or read book Veterinary Herbal Medicine written by Susan G. Wynn and published by Elsevier Health Sciences. This book was released on 2006-11-29 with total page 736 pages. Available in PDF, EPUB and Kindle. Book excerpt: This full-color reference offers practical, evidence-based guidance on using more than 120 medicinal plants, including how to formulate herbal remedies to treat common disease conditions. A body-systems based review explores herbal medicine in context, offering information on toxicology, drug interactions, quality control, and other key topics. More than 120 herbal monographs provide quick access to information on the historical use of the herb in humans and animals, supporting studies, and dosing information. Includes special dosing, pharmacokinetics, and regulatory considerations when using herbs for horses and farm animals. Expanded pharmacology and toxicology chapters provide thorough information on the chemical basis of herbal medicine. Explores the evolutionary relationship between plants and mammals, which is the basis for understanding the unique physiologic effects of herbs. Includes a body systems review of herbal remedies for common disease conditions in both large and small animals. Discusses special considerations for the scientific research of herbs, including complex and individualized interventions that may require special design and nontraditional outcome goals.
Book Synopsis Safe Management of Wastes from Health-care Activities by : Yves Chartier
Download or read book Safe Management of Wastes from Health-care Activities written by Yves Chartier and published by World Health Organization. This book was released on 2014 with total page 327 pages. Available in PDF, EPUB and Kindle. Book excerpt: This is the second edition of the WHO handbook on the safe, sustainable and affordable management of health-care waste--commonly known as "the Blue Book". The original Blue Book was a comprehensive publication used widely in health-care centers and government agencies to assist in the adoption of national guidance. It also provided support to committed medical directors and managers to make improvements and presented practical information on waste-management techniques for medical staff and waste workers. It has been more than ten years since the first edition of the Blue Book. During the intervening period, the requirements on generators of health-care wastes have evolved and new methods have become available. Consequently, WHO recognized that it was an appropriate time to update the original text. The purpose of the second edition is to expand and update the practical information in the original Blue Book. The new Blue Book is designed to continue to be a source of impartial health-care information and guidance on safe waste-management practices. The editors' intention has been to keep the best of the original publication and supplement it with the latest relevant information. The audience for the Blue Book has expanded. Initially, the publication was intended for those directly involved in the creation and handling of health-care wastes: medical staff, health-care facility directors, ancillary health workers, infection-control officers and waste workers. This is no longer the situation. A wider range of people and organizations now have an active interest in the safe management of health-care wastes: regulators, policy-makers, development organizations, voluntary groups, environmental bodies, environmental health practitioners, advisers, researchers and students. They should also find the new Blue Book of benefit to their activities. Chapters 2 and 3 explain the various types of waste produced from health-care facilities, their typical characteristics and the hazards these wastes pose to patients, staff and the general environment. Chapters 4 and 5 introduce the guiding regulatory principles for developing local or national approaches to tackling health-care waste management and transposing these into practical plans for regions and individual health-care facilities. Specific methods and technologies are described for waste minimization, segregation and treatment of health-care wastes in Chapters 6, 7 and 8. These chapters introduce the basic features of each technology and the operational and environmental characteristics required to be achieved, followed by information on the potential advantages and disadvantages of each system. To reflect concerns about the difficulties of handling health-care wastewaters, Chapter 9 is an expanded chapter with new guidance on the various sources of wastewater and wastewater treatment options for places not connected to central sewerage systems. Further chapters address issues on economics (Chapter 10), occupational safety (Chapter 11), hygiene and infection control (Chapter 12), and staff training and public awareness (Chapter 13). A wider range of information has been incorporated into this edition of the Blue Book, with the addition of two new chapters on health-care waste management in emergencies (Chapter 14) and an overview of the emerging issues of pandemics, drug-resistant pathogens, climate change and technology advances in medical techniques that will have to be accommodated by health-care waste systems in the future (Chapter 15).
Book Synopsis Risk Assessment in the Federal Government by : National Research Council
Download or read book Risk Assessment in the Federal Government written by National Research Council and published by National Academies Press. This book was released on 1983-02-01 with total page 206 pages. Available in PDF, EPUB and Kindle. Book excerpt: The regulation of potentially hazardous substances has become a controversial issue. This volume evaluates past efforts to develop and use risk assessment guidelines, reviews the experience of regulatory agencies with different administrative arrangements for risk assessment, and evaluates various proposals to modify procedures. The book's conclusions and recommendations can be applied across the entire field of environmental health.
Book Synopsis Promoting Access to Medical Technologies and Innovation - Intersections between Public Health, Intellectual Property and Trade by : World Intellectual Property Organization
Download or read book Promoting Access to Medical Technologies and Innovation - Intersections between Public Health, Intellectual Property and Trade written by World Intellectual Property Organization and published by WIPO. This book was released on 2013 with total page 259 pages. Available in PDF, EPUB and Kindle. Book excerpt: This study has emerged from an ongoing program of trilateral cooperation between WHO, WTO and WIPO. It responds to an increasing demand, particularly in developing countries, for strengthened capacity for informed policy-making in areas of intersection between health, trade and IP, focusing on access to and innovation of medicines and other medical technologies.
Book Synopsis Tolerable upper intake levels for vitamins and minerals by : European Commission. Scientific Committee on Food
Download or read book Tolerable upper intake levels for vitamins and minerals written by European Commission. Scientific Committee on Food and published by . This book was released on 2006 with total page 478 pages. Available in PDF, EPUB and Kindle. Book excerpt:
Book Synopsis Improving Drug Safety — A Joint Responsibility by : Rolf Dinkel
Download or read book Improving Drug Safety — A Joint Responsibility written by Rolf Dinkel and published by Springer Science & Business Media. This book was released on 2013-03-07 with total page 340 pages. Available in PDF, EPUB and Kindle. Book excerpt: As the focus on pharmaceuticals has broadened from concern for their cost and effectiveness to their real and potential risks and benefits, a critical question has been raised: whose responsibility is it to improve drug safety? In April 1990, this question became the theme for a conference at Wolfsberg, Switzerland, near the shores of Lake Constance. Called an "international dialogue conference" by its organizers, the meeting brought together leaders from the pharmaceutical industry, regulatory authorities, academia, medicine, consumer organizations and the media. Opening addresses were given by representatives of the Council for International Organizations of Medical Sciences (CIOMS), the International Federation of Pharmaceutical Manufacturers Associations (IFPMA), the Swiss International Pharmaceutical Agency, and the RAD-AR Consortium. This book documents the papers presented and discussions held at this conference, which took the topic of risks and benefits of drug therapy one step further to responsibility. It includes a rich menu of issues for those who care about the evaluation of drug therapy, the ethics behind it, the expectations of the patient, and the role of traditional and nontraditional drug safety communica tions. The ideas expressed here come from different parts of the world but relate to common drug safety problems, observations, and scientific assessments; they provide insights into innovative approaches, cautious changes, and desired actions. The papers in this volume are broadly divided into conceptual perspectives (ethics, how the knowledge about drug risks and benefits is generated and appraised, the expectations in drug safety) and operational perspectives (communication, discussion, and action).
Book Synopsis Finding What Works in Health Care by : Institute of Medicine
Download or read book Finding What Works in Health Care written by Institute of Medicine and published by National Academies Press. This book was released on 2011-07-20 with total page 267 pages. Available in PDF, EPUB and Kindle. Book excerpt: Healthcare decision makers in search of reliable information that compares health interventions increasingly turn to systematic reviews for the best summary of the evidence. Systematic reviews identify, select, assess, and synthesize the findings of similar but separate studies, and can help clarify what is known and not known about the potential benefits and harms of drugs, devices, and other healthcare services. Systematic reviews can be helpful for clinicians who want to integrate research findings into their daily practices, for patients to make well-informed choices about their own care, for professional medical societies and other organizations that develop clinical practice guidelines. Too often systematic reviews are of uncertain or poor quality. There are no universally accepted standards for developing systematic reviews leading to variability in how conflicts of interest and biases are handled, how evidence is appraised, and the overall scientific rigor of the process. In Finding What Works in Health Care the Institute of Medicine (IOM) recommends 21 standards for developing high-quality systematic reviews of comparative effectiveness research. The standards address the entire systematic review process from the initial steps of formulating the topic and building the review team to producing a detailed final report that synthesizes what the evidence shows and where knowledge gaps remain. Finding What Works in Health Care also proposes a framework for improving the quality of the science underpinning systematic reviews. This book will serve as a vital resource for both sponsors and producers of systematic reviews of comparative effectiveness research.
Book Synopsis Current Challenges in Pharmacovigilance by : World Health Organization
Download or read book Current Challenges in Pharmacovigilance written by World Health Organization and published by . This book was released on 2001-01-01 with total page 381 pages. Available in PDF, EPUB and Kindle. Book excerpt: In spite of recent progress in the harmonization of terminology and processes affecting work on the clinical safety of medicines consensus is needed on standards for many difficult aspects of day-to-day pharmacovigilance that continue to pose problems for both the pharmaceutical industry and drug regulators. The CIOMS V Working Group has generated proposals for pragmatic approaches to dealing with such issues as: classification and handling of individual safety case reports from a variety of sources (spontaneous consumer reports solicited reports literature the Internet observational studies and secondary data bases disease and other registries regulatory ADR databases and licensor-licensee interactions); new approaches to case management and regulatory reporting practices (proper clinical evaluation of cases incidental vs other events patient and reporter identifiability seriousness criteria expectedness criteria case follow-up criteria and the role and structure of case narratives); improvements and efficiencies in the format content and reporting of periodic safety update reports (PSURs) (including results of an industry survey on PSUR workloads and practices; proposals for high case volume and long time-period reports simplification of certain PSURs summary bridging reports addendum reports license renewal reports for EU and Japan dealing with old products and other technical details); determination and use of population exposure (denominator) data (sources of data and a guide to analytical approaches for a variety of circumstances).The Group has also taken stock of the current state of expedited and periodic clinical safety reporting requirements around the world with summary data on regulations from more than 60 countries. Recommendations are made for enhancing the harmonization steps already taken as a result of previous CIOMS publications and the ICH process. In addition to dealing with unfinished and unresolved issues from previous CIOMS initiatives the report covers many emerging topics such as those involving new technologies. Its 20 Appendices provide a wealth of detailed explanations and reference information. It is the most comprehensive and recent treatment of difficult pharmacovigilance issues affecting the working practices and systems of drug safety and other pharmaceutical professionals.
Book Synopsis Cleaner Technologies Substitutes Assessment by : Lori E. Kincaid
Download or read book Cleaner Technologies Substitutes Assessment written by Lori E. Kincaid and published by . This book was released on 1997 with total page 544 pages. Available in PDF, EPUB and Kindle. Book excerpt:
Author :Organisation for Economic Co-Operation and Development (OECD) Publisher :IWA Publishing ISBN 13 :1789061814 Total Pages :138 pages Book Rating :4.7/5 (89 download)
Book Synopsis Pharmaceutical Residues in Freshwater: Hazards and Policy Responses by : Organisation for Economic Co-Operation and Development (OECD)
Download or read book Pharmaceutical Residues in Freshwater: Hazards and Policy Responses written by Organisation for Economic Co-Operation and Development (OECD) and published by IWA Publishing. This book was released on 2020-07-15 with total page 138 pages. Available in PDF, EPUB and Kindle. Book excerpt: This report calls for a better understanding of the effects of pharmaceutical residues in the environment, greater international collaboration and accountability distribution, and policy actions to prevent and remedy emerging concerns. Laboratory and field tests show traces of oral contraceptives causing the feminisation of fish and amphibians, and residues of psychiatric drugs altering fish behaviour. Antimicrobial resistance, linked to the overuse of antibiotics, has rapidly escalated into a global health crisis. Unless adequate measures are taken to manage the risks, pharmaceutical residues will increasingly be released into the environment as ageing populations, advances in healthcare, and intensification of meat and fish production spur the demand for pharmaceuticals worldwide. The report outlines a collective, life‑cycle approach to managing pharmaceuticals in the environment. A policy mix of source‑directed, use‑orientated and end‑of‑pipe measures, involving several policy sectors, can help to improve health and protect the environment.
Book Synopsis Investing to Overcome the Global Impact of Neglected Tropical Diseases by : World Health Organization
Download or read book Investing to Overcome the Global Impact of Neglected Tropical Diseases written by World Health Organization and published by World Health Organization. This book was released on 2015-08-05 with total page 211 pages. Available in PDF, EPUB and Kindle. Book excerpt: "The presence, or absence, of neglected tropical diseases (NTDs) can be seen as a proxy for poverty and for the success of interventions aimed at reducing poverty. Today, coverage of the public-health interventions recommended by the World Health Organization (WHO) against NTDs may be interpreted as a proxy for universal health coverage and shared prosperity - in short, a proxy for coverage against neglect. As the world's focus shifts from development to sustainable development, from poverty eradication to shared prosperity, and from disease-specific goals to universal health coverage, control of NTDs will assume an important role towards the target of achieving universal health coverage, including individual financial risk protection. Success in overcoming NTDs is a "litmus test" for universal health coverage against NTDs in endemic countries. The first WHO report on NTDs (2010) set the scene by presenting the evidence for how these interventions had produced results. The second report (2013) assessed the progress made in deploying them and detailed the obstacles to their implementation. This third report analyses for the first time the investments needed to achieve the scale up of implementation required to achieve the targets of the WHO Roadmap on NTDs and universal coverage against NTDs. INVESTING TO OVERCOME THE GLOBAL IMPACT OF NEGLECTED TROPICAL DISEASES presents an investment strategy for NTDs and analyses the specific investment case for prevention, control, elimination and eradication of 12 of the 17 NTDs. Such an analysis is justified following the adoption by the Sixty-sixth World Health Assembly in 2013 of resolution WHA6612 on neglected tropical diseases, which called for sufficient and predictable funding to achieve the Roadmap's targets and sustain control efforts. The report cautions, however, that it is wise investment and not investment alone that will yield success. The report registers progress and challenges and signals those that lie ahead. Climate change is expected to increase the spread of several vector-borne NTDs, notably dengue, transmission of which is directly influenced by temperature, rainfall, relative humidity and climate variability primarily through their effects on the vector. Investments in vector-borne diseases will avoid the potentially catastrophic expenditures associated with their control. The presence of NTDs will thereby signal an early warning system for climate-sensitive diseases. The ultimate goal is to deliver enhanced and equitable interventions to the most marginalized populations in the context of a changing public-health and investment landscape to ensure that all peoples affected by NTDs have an opportunity to lead healthier and wealthier lives."--Publisher's description.
Book Synopsis Guidelines for Drinking-water Quality by : World Health Organization
Download or read book Guidelines for Drinking-water Quality written by World Health Organization and published by World Health Organization. This book was released on 1993 with total page 260 pages. Available in PDF, EPUB and Kindle. Book excerpt: This volume describes the methods used in the surveillance of drinking water quality in the light of the special problems of small-community supplies, particularly in developing countries, and outlines the strategies necessary to ensure that surveillance is effective.
Book Synopsis Human Pharmaceuticals, Hormones and Fragrances by : Thomas Ternes
Download or read book Human Pharmaceuticals, Hormones and Fragrances written by Thomas Ternes and published by IWA Publishing. This book was released on 2007-01-30 with total page 475 pages. Available in PDF, EPUB and Kindle. Book excerpt: The observed concentrations of pharmaceuticals and personal care products (PPCPs) in raw wastewater confirm that municipal wastewater represents the main disposal pathway for the PPCPs consumed in households, hospitals and industry. In sewage treatment plant effluents most PPCPs are still present, since many of these polar and persistent compounds are being removed only partially or, in some cases, not at all. Treated wastewater therefore represents an important point source for PPCPs into the environment. After passing a sewage treatment plant the treated wastewater is mostly discharged into rivers and streams or sometimes used to irrigate fields. If drinking water is produced using resources containing a substantial proportion of treated wastewater (e.g. from river water downstream of communities) the water cycle is closed and indirect potable reuse occurs. Human Pharmaceuticals, Hormones and Fragrances provides an overview of the occurrence, analytics, removal and environmental risk of pharmaceuticals and personal care products in wastewater, surface water and drinking water. The book covers all aspects of the fate and removal of PPCPs in the whole water cycle: consumption and occurrence, analytical methods, the legal background, environmental risk assessment, human and animal toxicology, source control options, wastewater and drinking water treatment as well as indirect reuse. The book presents a summary of the results obtained during the EU project "Poseidon", combined with further expert knowledge on the field, and is written at a level appropriate for professionals involved in management of water resource quality. Professionals in the field including decision makers, engineers and scientists, as well as students entering the field, will find this an invaluable source of information. First comprehensive study on the assessment, fate and removal of pharmaceuticals and personal care products in wastewater and drinking water treatment. Emphasises the importance of micropollutants in the water cycle, provides methods for quantifying their fate and technologies for their removal.
Author :Joint FAO/WHO Codex Alimentarius Commission Publisher :Food and Agriculture Organization of the United Nations ISBN 13 : Total Pages :224 pages Book Rating :4.:/5 (31 download)
Book Synopsis Procedural Manual by : Joint FAO/WHO Codex Alimentarius Commission
Download or read book Procedural Manual written by Joint FAO/WHO Codex Alimentarius Commission and published by Food and Agriculture Organization of the United Nations. This book was released on 2011 with total page 224 pages. Available in PDF, EPUB and Kindle. Book excerpt: The Procedural Manual of the Codex Alimentarius Commission is intended to help Member Governments participate effectively in the work of the joint FAO/WHO Food Standards Programme. The manual is particularly useful for national delegations attending Codex meetings and for international organizations attending as observers. It sets out the basic Rules of Procedure, procedures for the elaboration of Codex standards and related texts, basic definitions and guidelines for the operation of Codex committees. It also gives the membership of the Codex Alimentarius Commission. Also published in French and Spanish.
Download or read book Edible Insects written by Arnold van Huis and published by Bright Sparks. This book was released on 2013 with total page 0 pages. Available in PDF, EPUB and Kindle. Book excerpt: Edible insects have always been a part of human diets, but in some societies there remains a degree of disdain and disgust for their consumption. Although the majority of consumed insects are gathered in forest habitats, mass-rearing systems are being developed in many countries. Insects offer a significant opportunity to merge traditional knowledge and modern science to improve human food security worldwide. This publication describes the contribution of insects to food security and examines future prospects for raising insects at a commercial scale to improve food and feed production, diversify diets, and support livelihoods in both developing and developed countries. It shows the many traditional and potential new uses of insects for direct human consumption and the opportunities for and constraints to farming them for food and feed. It examines the body of research on issues such as insect nutrition and food safety, the use of insects as animal feed, and the processing and preservation of insects and their products. It highlights the need to develop a regulatory framework to govern the use of insects for food security. And it presents case studies and examples from around the world. Edible insects are a promising alternative to the conventional production of meat, either for direct human consumption or for indirect use as feedstock. To fully realise this potential, much work needs to be done by a wide range of stakeholders. This publication will boost awareness of the many valuable roles that insects play in sustaining nature and human life, and it will stimulate debate on the expansion of the use of insects as food and feed.
