Practical Approaches To Risk Minimisation For Medicinal Products

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Practical Approaches to Risk Minimisation for Medicinal Products

World Health Organization
Practical Approaches to Risk Minimisation for Medicinal Products Book PDF

Author : World Health Organization
Publisher : Unknown
Page : 0 pages
File Size : 55,9 Mb
Release : 2014
Category : Drugs
ISBN : 9290360844

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Practical Approaches to Risk Minimisation for Medicinal Products by World Health Organization Pdf

Risk management of medicines is a wide and rapidly evolving concept and practice, following a medicine throughout its lifecycle, from first administration in humans through clinical studies and then marketing in the patient population at large. Previous reports from CIOMS I - VIII provided practical guidance in some essential components of risk management such as terminology and reporting of adverse drug reactions, management of safety information from clinical trials, and safety signal detection. Beyond the detection, identification, and characterization of risk, "risk minimization" is used as an umbrella term for the prevention or mitigation of an undesirable outcome. Risk management always includes tools for "routine risk minimization" such as product information, the format depending on the jurisdiction, to inform the patient and the prescriber, all of which serve to prevent or mitigate adverse effects. Until this current CIOMS IX document, limited guidance has been available on how to determine which risks need "additional risk minimization," select the appropriate tools, apply and implement such tools globally and locally, and measure if they are effective and valuable. Included in the report is a CIOMS framework for the evaluation of effectiveness of risk minimization, a discussion of future trends and developments, an annex specifically addressing vaccines, and examples from real life.

Therapeutic Risk Management of Medicines

Stephen J. Mayall,Anjan Swapu Banerjee
Therapeutic Risk Management of Medicines Book PDF

Author : Stephen J. Mayall,Anjan Swapu Banerjee
Publisher : Elsevier
Page : 448 pages
File Size : 45,8 Mb
Release : 2014-04-16
Category : Medical
ISBN : 9781908818270

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Therapeutic Risk Management of Medicines by Stephen J. Mayall,Anjan Swapu Banerjee Pdf

Therapeutic risk management of medicines is an authoritative and practical guide on developing, implementing and evaluating risk management plans for medicines globally. It explains how to assess risks and benefit-risk balance, design and roll out risk minimisation and pharmacovigilance activities, and interact effectively with key stakeholders. A more systematic approach for managing the risks of medicines arose following a number of high-profile drug safety incidents and a need for better access to effective but potentially risky treatments. Regulatory requirements have evolved rapidly over the past decade. Risk management plans (RMPs) are mandatory for new medicinal products in the EU and a Risk Evaluation and Mitigation Strategy (REMS) is needed for certain drugs in the US. This book is an easy-to-read resource that complements current regulatory guidance, by exploring key areas and practical implications in greater detail. It is structured into chapters encompassing a background to therapeutic risk management, strategies for developing RMPs, implementation of RMPs, and the continuing evolution of the risk management field.The topic is of critical importance not only to the pharmaceutical and biotechnology industries, but also regulators and healthcare policymakers.Some chapters feature contributions from selected industry experts. An up-to-date practical guide on conceiving, designing, and implementing global therapeutic risk management plans for medicines A number of useful frameworks are presented which add impact to RMPs (Risk Management Plans), together with regional specific information (European Union, United States, and Japan) A comprehensive guide for performing risk management more effectively throughout a product’s life-cycle

Pharmacovigilance: A Practical Approach

Thao Doan,Cheryl Renz,Fabio Lievano,Mondira Bhattacharya,Linda Scarazzini
Pharmacovigilance A Practical Approach Book PDF

Author : Thao Doan,Cheryl Renz,Fabio Lievano,Mondira Bhattacharya,Linda Scarazzini
Publisher : Elsevier Health Sciences
Page : 228 pages
File Size : 49,5 Mb
Release : 2018-07-31
Category : Medical
ISBN : 9780323581172

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Pharmacovigilance: A Practical Approach by Thao Doan,Cheryl Renz,Fabio Lievano,Mondira Bhattacharya,Linda Scarazzini Pdf

Written by experts in the field of pharmacovigilance and patient safety, this concise resource provides a succinct, easy-to-digest overview of an increasingly critical area of medical safety. Drs. Thao Doan, Fabio Lievano, Mondira Bhattacharya, and Linda Scarazzini provide essential information for health care professionals, clinical researchers, and regulators who need a comprehensive, up-to-date source of information on the principles and practice of pharmacovigilance.

Clinical Practice Guidelines We Can Trust

Institute of Medicine,Board on Health Care Services,Committee on Standards for Developing Trustworthy Clinical Practice Guidelines
Clinical Practice Guidelines We Can Trust Book PDF

Author : Institute of Medicine,Board on Health Care Services,Committee on Standards for Developing Trustworthy Clinical Practice Guidelines
Publisher : National Academies Press
Page : 217 pages
File Size : 51,6 Mb
Release : 2011-06-16
Category : Medical
ISBN : 9780309216463

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Clinical Practice Guidelines We Can Trust by Institute of Medicine,Board on Health Care Services,Committee on Standards for Developing Trustworthy Clinical Practice Guidelines Pdf

Advances in medical, biomedical and health services research have reduced the level of uncertainty in clinical practice. Clinical practice guidelines (CPGs) complement this progress by establishing standards of care backed by strong scientific evidence. CPGs are statements that include recommendations intended to optimize patient care. These statements are informed by a systematic review of evidence and an assessment of the benefits and costs of alternative care options. Clinical Practice Guidelines We Can Trust examines the current state of clinical practice guidelines and how they can be improved to enhance healthcare quality and patient outcomes. Clinical practice guidelines now are ubiquitous in our healthcare system. The Guidelines International Network (GIN) database currently lists more than 3,700 guidelines from 39 countries. Developing guidelines presents a number of challenges including lack of transparent methodological practices, difficulty reconciling conflicting guidelines, and conflicts of interest. Clinical Practice Guidelines We Can Trust explores questions surrounding the quality of CPG development processes and the establishment of standards. It proposes eight standards for developing trustworthy clinical practice guidelines emphasizing transparency; management of conflict of interest ; systematic review-guideline development intersection; establishing evidence foundations for and rating strength of guideline recommendations; articulation of recommendations; external review; and updating. Clinical Practice Guidelines We Can Trust shows how clinical practice guidelines can enhance clinician and patient decision-making by translating complex scientific research findings into recommendations for clinical practice that are relevant to the individual patient encounter, instead of implementing a one size fits all approach to patient care. This book contains information directly related to the work of the Agency for Healthcare Research and Quality (AHRQ), as well as various Congressional staff and policymakers. It is a vital resource for medical specialty societies, disease advocacy groups, health professionals, private and international organizations that develop or use clinical practice guidelines, consumers, clinicians, and payers.

Benefit-Risk Assessment Methods in Medical Product Development

Qi Jiang,Weili He
Benefit Risk Assessment Methods in Medical Product Development Book PDF

Author : Qi Jiang,Weili He
Publisher : CRC Press
Page : 255 pages
File Size : 43,8 Mb
Release : 2017-12-19
Category : Mathematics
ISBN : 9781315355016

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Benefit-Risk Assessment Methods in Medical Product Development by Qi Jiang,Weili He Pdf

Guides You on the Development and Implementation of B–R Evaluations Benefit–Risk Assessment Methods in Medical Product Development: Bridging Qualitative and Quantitative Assessments provides general guidance and case studies to aid practitioners in selecting specific benefit–risk (B–R) frameworks and quantitative methods. Leading experts from industry, regulatory agencies, and academia present practical examples, lessons learned, and best practices that illustrate how to conduct structured B–R assessment in clinical development and regulatory submission. The first section of the book discusses the role of B–R assessments in medicine development and regulation, the need for both a common B–R framework and patient input into B–R decisions, and future directions. The second section focuses on legislative and regulatory policy initiatives as well as decisions made at the U.S. FDA’s Center for Devices and Radiological Health. The third section examines key elements of B–R evaluations in a product’s life cycle, such as uncertainty evaluation and quantification, quantifying patient B–R trade-off preferences, ways to identify subgroups with the best B–R profiles, and data sources used to assist B–R assessment. The fourth section equips practitioners with tools to conduct B–R evaluations, including assessment methodologies, a quantitative joint modeling and joint evaluation framework, and several visualization tools. The final section presents a rich collection of case studies. With top specialists sharing their in-depth knowledge, thought-provoking considerations, and practical advice, this book offers comprehensive coverage of B–R evaluation methods, tools, and case studies. It gives practitioners a much-needed toolkit to develop and conduct their own B–R evaluations.

Practical Aspects of Signal Detection in Pharmacovigilance

Council for International Organizations of Medical Sciences (CIOMS)
Practical Aspects of Signal Detection in Pharmacovigilance Book PDF

Author : Council for International Organizations of Medical Sciences (CIOMS)
Publisher : Cioms
Page : 0 pages
File Size : 42,9 Mb
Release : 2010
Category : Drug monitoring
ISBN : 9290360828

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Practical Aspects of Signal Detection in Pharmacovigilance by Council for International Organizations of Medical Sciences (CIOMS) Pdf

In recent years public expectations for rapid identification and prompt management of emerging drug safety issues have grown swiftly. Over a similar timeframe, the move from paper-based adverse event reporting systems to electronic capture and rapid transmission of data has resulted in the accrual of substantial datasets capable of complex analysis and querying by industry, regulators and other public health organizations. These two drivers have created a fertile environment for pharmacovigilance scientists, information technologists and statistical experts, working together, to deliver novel approaches to detect signals from these extensive and quickly growing datasets, and to manage them appropriately. In following this exciting story, this report looks at the practical consequences of these developments for pharmacovigilance practitioners. The report provides a comprehensive resource for those considering how to strengthen their pharmacovigilance systems and practices, and to give practical advice. But the report does not specify instant solutions. These will inevitably be situation specific and require careful consideration taking into account local needs. However, the CIOMS Working Group VIII is convinced that the combination of methods and a clear policy on the management of signals will strengthen current systems. Finally, in looking ahead, the report anticipates a number of ongoing developments, including techniques with wider applicability to other data forms than individual case reports. The ultimate test for pharmacovigilance systems is the demonstration of public health benefit and it is this test which signal detection methodologies need to meet if the expectations of all stakeholders are to be fulfilled.

Benefit-Risk Assessment Methods in Medical Product Development

Qi Jiang,Weili He
Benefit Risk Assessment Methods in Medical Product Development Book PDF

Author : Qi Jiang,Weili He
Publisher : CRC Press
Page : 296 pages
File Size : 46,6 Mb
Release : 2017-12-19
Category : Mathematics
ISBN : 9781482259377

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Benefit-Risk Assessment Methods in Medical Product Development by Qi Jiang,Weili He Pdf

Guides You on the Development and Implementation of B–R Evaluations Benefit–Risk Assessment Methods in Medical Product Development: Bridging Qualitative and Quantitative Assessments provides general guidance and case studies to aid practitioners in selecting specific benefit–risk (B–R) frameworks and quantitative methods. Leading experts from industry, regulatory agencies, and academia present practical examples, lessons learned, and best practices that illustrate how to conduct structured B–R assessment in clinical development and regulatory submission. The first section of the book discusses the role of B–R assessments in medicine development and regulation, the need for both a common B–R framework and patient input into B–R decisions, and future directions. The second section focuses on legislative and regulatory policy initiatives as well as decisions made at the U.S. FDA’s Center for Devices and Radiological Health. The third section examines key elements of B–R evaluations in a product’s life cycle, such as uncertainty evaluation and quantification, quantifying patient B–R trade-off preferences, ways to identify subgroups with the best B–R profiles, and data sources used to assist B–R assessment. The fourth section equips practitioners with tools to conduct B–R evaluations, including assessment methodologies, a quantitative joint modeling and joint evaluation framework, and several visualization tools. The final section presents a rich collection of case studies. With top specialists sharing their in-depth knowledge, thought-provoking considerations, and practical advice, this book offers comprehensive coverage of B–R evaluation methods, tools, and case studies. It gives practitioners a much-needed toolkit to develop and conduct their own B–R evaluations.

An Introduction to Pharmacovigilance

Patrick Waller,Mira Harrison-Woolrych
An Introduction to Pharmacovigilance Book PDF

Author : Patrick Waller,Mira Harrison-Woolrych
Publisher : John Wiley & Sons
Page : 194 pages
File Size : 46,9 Mb
Release : 2017-05-01
Category : Medical
ISBN : 9781119289746

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An Introduction to Pharmacovigilance by Patrick Waller,Mira Harrison-Woolrych Pdf

Pharmacovigilance is the science and activities relating to the detection, assessment, understanding and prevention of adverse effects or any other drug-related problems. This introductory guide is designed to aid the rapid understanding of the key principles of pharmacovigilance. Packed full of examples illustrating drug safety issues it not only covers the processes involved, but the regulatory aspects and ethical and societal considerations of pharmacovigilance. Covering the basics step-by-step, this book is perfect for beginners and is essential reading for those new to drug safety departments and pharmaceutical medicine students. The second edition is thoroughly revised and updated throughout and includes a new chapter on clinical aspects of pharmacovigilance.

ICH Quality Guidelines

Andrew Teasdale,David Elder,Raymond W. Nims
ICH Quality Guidelines Book PDF

Author : Andrew Teasdale,David Elder,Raymond W. Nims
Publisher : John Wiley & Sons
Page : 740 pages
File Size : 53,7 Mb
Release : 2017-10-09
Category : Medical
ISBN : 9781118971116

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ICH Quality Guidelines by Andrew Teasdale,David Elder,Raymond W. Nims Pdf

Examining the implications and practical implementation of multi-disciplinary International Conference on Harmonization (ICH) topics, this book gives an integrated view of how the guidelines inform drug development strategic planning and decision-making. • Addresses a consistent need for interpretation, training, and implementation examples of ICH guidelines via case studies • Offers a primary reference point for practitioners addressing the dual challenge of interpretation and practical implementation of ICH guidelines • Uses case studies to help readers understand and apply ICH guidelines • Provides valuable insights into guidelines development, with chapters by authors involved in generating or with experience implementing the guidelines • Includes coverage of stability testing, analytical method validation, impurities, biotechnology drugs and products, and good manufacturing practice (GMP)

Pharmacovigilance (English Edition)

Dr. Agnimitra Dinda,Monika Saxena
Pharmacovigilance English Edition Book PDF

Author : Dr. Agnimitra Dinda,Monika Saxena
Publisher : Thakur Publication Private Limited
Page : 184 pages
File Size : 40,6 Mb
Release : 2021-03-10
Category : Education
ISBN : 9789390972838

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Pharmacovigilance (English Edition) by Dr. Agnimitra Dinda,Monika Saxena Pdf

Buy E-Book of Pharmacovigilance (English Edition) Book For B.Pharm 8th Semester of U.P. State Universities

Improved FMEA Methods for Proactive Healthcare Risk Analysis

Hu-Chen Liu
Improved FMEA Methods for Proactive Healthcare Risk Analysis Book PDF

Author : Hu-Chen Liu
Publisher : Springer
Page : 325 pages
File Size : 46,7 Mb
Release : 2019-02-14
Category : Technology & Engineering
ISBN : 9789811363665

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Improved FMEA Methods for Proactive Healthcare Risk Analysis by Hu-Chen Liu Pdf

This book offers an in-depth and systematic introduction to improved failure mode and effects analysis (FMEA) methods for proactive healthcare risk analysis. Healthcare risk management has become an increasingly important issue for hospitals and managers. As a prospective reliability analysis technique, FMEA has been widely used for identifying and eliminating known and potential failures in systems, designs, products or services. However, the traditional FMEA has a number of weaknesses when applied to healthcare risk management. This book provides valuable insights into useful FMEA methods and practical examples that can be considered when applying FMEA to enhance the reliability and safety of the healthcare system. This book is very interesting for practitioners and academics working in the fields of healthcare risk management, quality management, operational research, and management science and engineerin. It can be considered as the guiding document for how a healthcare organization proactively identifies, manages and mitigates the risk of patient harm. This book also serves as a valuable reference for postgraduate and senior undergraduate students.

Data and Safety Monitoring Committees in Clinical Trials

Jay Herson
Data and Safety Monitoring Committees in Clinical Trials Book PDF

Author : Jay Herson
Publisher : CRC Press
Page : 266 pages
File Size : 47,9 Mb
Release : 2016-12-19
Category : Mathematics
ISBN : 9781498784122

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Data and Safety Monitoring Committees in Clinical Trials by Jay Herson Pdf

Praise for the first edition: "Given the author’s years of experience as a statistician and as a founder of the first DMC in pharmaceutical industry trials, I highly recommend this book—not only for experts because of its cogent and organized presentation, but more importantly for young investigators who are seeking information about the logistical and philosophical aspects of a DMC." -S. T. Ounpraseuth, The American Statistician In the first edition of this well-regarded book, the author provided a groundbreaking and definitive guide to best practices in pharmaceutical industry data monitoring committees (DMCs). Maintaining all the material from the first edition and adding substantial new material, Data and Safety Monitoring Committees in Clinical Trials, Second Edition is ideal for training professionals to serve on their first DMC as well as for experienced clinical and biostatistical DMC members, sponsor and regulatory agency staff. The second edition guides the reader through newly emerging DMC responsibilities brought about by regulations emphasizing risk vs benefit and the emergence of risk-based monitoring. It also provides the reader with many new statistical methods, clinical trial designs and clinical terminology that have emerged since the first edition. The references have been updated and the very popular end-of-chapter Q&A section has been supplemented with many new experiences since the first edition. New to the Second Edition: Presents statistical methods, tables, listings and graphs appropriate for safety review, efficacy analysis and risk vs benefit analysis, SPERT and PRISMA initiatives. Newly added interim analysis for efficacy and futility section. DMC responsibilities in SUSARs (Serious Unexpected Serious Adverse Reactions), basket trials, umbrella trials, dynamic treatment strategies /SMART trials, pragmatic trials, biosimilar trials, companion diagnostics, etc. DMC responsibilities for data quality and fraud detection (Fraud Recovery Plan) Use of patient reported outcomes of safety Use of meta analysis and data outside the trial New ideas for training and compensation of DMC members Jay Herson is Senior Associate, Biostatistics, Johns Hopkins Bloomberg School of Public Health where he teaches courses on clinical trials and drug development based on his many years experience in clinical trials in academia and the pharmaceutical industry.

System Safety Engineering and Risk Assessment

Nicholas J. Bahr
System Safety Engineering and Risk Assessment Book PDF

Author : Nicholas J. Bahr
Publisher : CRC Press
Page : 444 pages
File Size : 44,7 Mb
Release : 2018-10-08
Category : Technology & Engineering
ISBN : 9781466551619

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System Safety Engineering and Risk Assessment by Nicholas J. Bahr Pdf

We all know that safety should be an integral part of the systems that we build and operate. The public demands that they are protected from accidents, yet industry and government do not always know how to reach this common goal. This book gives engineers and managers working in companies and governments around the world a pragmatic and reasonable approach to system safety and risk assessment techniques. It explains in easy-to-understand language how to design workable safety management systems and implement tested solutions immediately. The book is intended for working engineers who know that they need to build safe systems, but aren’t sure where to start. To make it easy to get started quickly, it includes numerous real-life engineering examples. The book’s many practical tips and best practices explain not only how to prevent accidents, but also how to build safety into systems at a sensible price. The book also includes numerous case studies from real disasters that describe what went wrong and the lessons learned. See What’s New in the Second Edition: New chapter on developing government safety oversight programs and regulations, including designing and setting up a new safety regulatory body, developing safety regulatory oversight functions and governance, developing safety regulations, and how to avoid common mistakes in government oversight Significantly expanded chapter on safety management systems, with many practical applications from around the world and information about designing and building robust safety management systems, auditing them, gaining internal support, and creating a safety culture New and expanded case studies and "Notes from Nick’s Files" (examples of practical applications from the author’s extensive experience) Increased international focus on world-leading practices from multiple industries with practical examples, common mistakes to avoid, and new thinking about how to build sustainable safety management systems New material on safety culture, developing leading safety performance indicators, safety maturity model, auditing safety management systems, and setting up a safety knowledge management system

Text book of Pharmacovigilance

Dr. Prashant Tiwari,Dr. Dileep Kumar, Dr. Dyandevi Mathure, Mr. Amit Jaswal
Text book of Pharmacovigilance Book PDF

Author : Dr. Prashant Tiwari,Dr. Dileep Kumar, Dr. Dyandevi Mathure, Mr. Amit Jaswal
Publisher : OrangeBooks Publication
Page : 136 pages
File Size : 49,7 Mb
Release : 2023-04-14
Category : Medical
ISBN : 8210379456XXX

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Text book of Pharmacovigilance by Dr. Prashant Tiwari,Dr. Dileep Kumar, Dr. Dyandevi Mathure, Mr. Amit Jaswal Pdf

Pharmacovigilance is used to detect, assess, understand, and prevent the adverse effects of medications. The need for safety monitoring has evolved around unfortunate incidents in history, with deaths caused by anesthesia and congenital malformations from thalidomide use. The purpose of this book is to present the case for the importance of pharmacovigilance, to record its growth and potential as a significant discipline within medical science, and to describe its impact on patient welfare and public health. This book is also be useful for the B. Pharma, Pharm D and M. Pharm students. The basic objective of pharmacovigilance is the safe use of drugs, patient safety, and, ultimately, safeguarding public health. To achieve this goal, national regulators and international organizations should empower healthcare professionals and the public to report more ADRs.

Practical Risk Management for EPC / Design-Build Projects

Walter A. Salmon
Practical Risk Management for EPC Design Build Projects Book PDF

Author : Walter A. Salmon
Publisher : John Wiley & Sons
Page : 314 pages
File Size : 43,6 Mb
Release : 2020-02-25
Category : Business & Economics
ISBN : 9781119596257

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Practical Risk Management for EPC / Design-Build Projects by Walter A. Salmon Pdf

Many of the books on construction risk management concentrate on theoretical approaches to the accurate assessment of the overall risks of taking on a new project. Less attention is paid to the typical risks to which the operational level of a project is exposed and how operational managers should approach those risks during project implementation. This book identifies precisely where the major EPC/Design-Build risks occur within an operational framework and shows how best to deal with those risks. The book attempts to offer practical advice, approaches and tools for dealing with risks to which the various operational departments are exposed.