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Author: World Health Organization
Publisher:
ISBN: 9789290360742
Category : Medical
Languages : en
Pages : 381
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Book Description
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.
Author: World Health Organization
Publisher:
ISBN: 9789290360742
Category : Medical
Languages : en
Pages : 381
Get Book Here
Book Description
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.
Author: Isabelle Romieu
Publisher: IARC Working Group Report
ISBN: 9789283225195
Category : Medical
Languages : en
Pages : 0
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Book Description
Understanding the relationship between energy balance and obesity is essential to develop effective prevention programs and policies. The International Agency for Research on Cancer convened a Working Group of world-leading experts in December 2015 to review the evidence regarding energy balance and obesity, with a focus on low- and middle-income countries, and to consider the following scientific questions: (i) Are the drivers of the obesity epidemic related only to energy excess and/or do specific foods or nutrients play a major role in this epidemic? (ii) What are the factors that modulate these associations? (iii) Which types of data and/or studies will further improve our understanding? This book provides summaries of the evidence from the literature as well as the Working Group's conclusions and recommendations to tackle the global epidemic of obesity.
Author: Intergovernmental Panel on Climate Change
Publisher: Cambridge University Press
ISBN: 1107025060
Category : Business & Economics
Languages : en
Pages : 593
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Book Description
Extreme weather and climate events, interacting with exposed and vulnerable human and natural systems, can lead to disasters. This Special Report explores the social as well as physical dimensions of weather- and climate-related disasters, considering opportunities for managing risks at local to international scales. SREX was approved and accepted by the Intergovernmental Panel on Climate Change (IPCC) on 18 November 2011 in Kampala, Uganda.
Author:
Publisher:
ISBN: 9789210563994
Category : Bankruptcy
Languages : en
Pages : 118
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Book Description
UNCITRAL model law on cross-border insolvency -- Guide to enactment and interpretation of the UNCITRAL model law on cross-border insolvency -- General assembly resolution 52/158 of 15 december 1997 -- decision of the united nations commission on international trade law
Author:
Publisher:
ISBN:
Category : Geophysics
Languages : en
Pages : 344
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Book Description
Author: Neil Hannan
Publisher: Springer
ISBN: 9811058768
Category : Law
Languages : en
Pages : 273
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Book Description
This book examines the effect of the adoption of the United Nations Committee on International Trade Law (UNCITRAL) Model Law on Cross-Border Insolvency in five common law jurisdictions, namely Australia, Canada, New Zealand, the United Kingdom, and the United States of America. It examines how each of those states has adopted, interpreted and applied the provisions of the Model Law, and highlights the effects of inconsistencies by examining jurisprudence in each of these countries, specifically how the Model Law affects existing principles of recognition of insolvency proceedings. The book examines how the UNCITRAL Guide to enactment of the Model Law has affected the interpretation of each of its articles and, in turn, the courts’ ability to interpret and hence give effect to the purposes of the Model Law. It also considers the ability of courts to refer to amendments made to the Guide after enactment of the Model Law in a state, thereby questioning whether the current inconsistencies in interpretation can be overcome by UNCITRAL amending the Guide.
Author: IARC Working Group on the Evaluation of Carcinogenic Risks to Humans
Publisher: IARC Monographs on the Evaluat
ISBN: 9789283201472
Category : Medical
Languages : en
Pages : 0
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Book Description
"This publication represents the views and expert opinions of an IARC Working Group on the Evaluation of Carcinogenic Risk to Humans, which met in Lyon, 8-15 October 2013."
Author: CIOMS Working Group III
Publisher: World Health Organization
ISBN: 9789290360704
Category : Drugs
Languages : en
Pages : 98
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Book Description
Author: Irit Mevorach
Publisher: Oxford University Press
ISBN: 0191085731
Category : Law
Languages : en
Pages : 262
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Book Description
A fresh and insightful guide to post-financial crisis cross-border insolvency, this book interrogates the current regime and sets out a framework for improving its future. In recent decades, and especially since the global financial crisis, a number of important initiatives have focused on developing the mechanisms for managing the insolvency of multinational enterprises and financial institutions. The book considers the effectiveness of the current system and identifies the gaps that could be bridged by adopting certain strategies and tools, to improve the system further. The book first discusses the theoretical debate regarding cross-border insolvency and surveys the strengths and weaknesses of the prevailing method-modified universalism in its application to both commercial entities and financial institutions, consequently identifying a single set of emerging norms. The book argues that adhering to these norms more robustly would enhance global welfare and produce the best outcomes for businesses and institutions. By drawing upon sources from international law as well as behavioural and economic theory, the book offers a blueprint for meeting the demands of future cross-border insolvencies. It considers how to translate modified universalism into binding international law and how to choose the right instrument for cross-border insolvency as well as the impact that instrument design has on decisions and choices. It explores how to encourage compliance and proposes mechanisms that could potentially overcome, or at least take into account, behavioural biases in decision-making.
Author: IARC Working Group on the Evaluation of Carcinogenic Risks to Humans
Publisher: International Agency for Research on Cancer
ISBN: 9789283201526
Category : Medical
Languages : en
Pages : 0
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Book Description
This volume of the IARC Monographs provides evaluations of the consumption of red meat and the consumption of processed meat. Red meat refers to unprocessed mammalian muscle meat (e.g. beef, veal, pork, lamb) including that which may be minced or frozen. Processed meat refers to meat that has been transformed through salting, curing, fermentation, smoking or other processes to enhance flavor or improve preservation. Most processed meats contain pork or beef, but may also contain other meats including poultry and offal (e.g. liver) or meat by-products such as blood. Red meat contains proteins of high biological value, and important micronutrients such as B vitamins, iron (both free iron and haem iron), and zinc. Carcinogens, including heterocyclic aromatic amines and polycyclic aromatic hydrocarbons, can be produced by cooking of meat, with greatest amounts generated at high temperatures by pan-frying, grilling, or barbecuing. Meat processing such as curing and smoking can result in formation of carcinogenic chemicals including N-nitroso compounds and polycyclic aromatic hydrocarbons. An IARC Monographs Working Group reviewed epidemiological evidence, animal bioassays, and mechanistic and other relevant data to reach conclusions as to the carcinogenic hazard to humans of the consumption of red meat and processed meat. The Working Group assessed more than 800 epidemiological studies that investigated the association of cancer (more than 15 types) with consumption of red meat or processed meat, including large cohorts in many countries, from several continents, with diverse ethnicities and diets.
