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| celgene risk management survey: Therapeutic Risk Management of Medicines Stephen J. Mayall, Anjan Swapu Banerjee, 2014-04-16 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 |
| celgene risk management survey: Patient Blood Management Hans Gombotz, Kai Zacharowski, Donat R. Spahn, 2015-11-10 Patient Blood Management (PBM) is an innovative clinical concept that aims to reduce the need for allogenic blood transfusions, cut health-care costs, and avert or correct the risk factors related to blood transfusion, thus minimizing the rate of side effects and complications. This comprehensive hands-on volume offers a three-point approach for the implementation of PBM to improve patient outcome, focusing on how to prevent or treat anemia, reduce blood loss, and increase anemia tolerance. The book also goes beyond preoperative PBM, with detailed accounts of coagulation disorder management and the administration of coagulation products and platelet concentrates. Special Features: Presents a clear three-pillar strategy for the application of PBM: diagnosis and treatment of anemia, reduction of peri-interventional blood loss, and optimization of the tolerance to anemia in the everyday clinical setting Covers issues such as PBM during surgery, requirements for modern transfusion medicine, ordering blood products, the role of pre-anesthesia clinics, benchmarking processes, and potential implications of PBM in the public health sector Overview of research in PBM including landmark studies and current clinical trials Boxes in each chapter highlighting key information, core statements, and summaries A multidisciplinary and international team of contributors experienced in PBM Patient Blood Management is a guide for clinicians and residents whose patients are at risk for anemia, coagulation disorders, or severe blood loss. Anesthesiologists, surgeons, and specialists involved in the use of blood and blood products can use the book for quick reference or to learn more about a leading-edge concept for optimizing patient safety and improving outcome. |
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| celgene risk management survey: The Role of NIH in Drug Development Innovation and Its Impact on Patient Access National Academies of Sciences, Engineering, and Medicine, Health and Medicine Division, Board on Health Sciences Policy, Board on Health Care Services, 2020-01-27 To explore the role of the National Institutes of Health (NIH) in innovative drug development and its impact on patient access, the Board on Health Care Services and the Board on Health Sciences Policy of the National Academies jointly hosted a public workshop on July 24â€25, 2019, in Washington, DC. Workshop speakers and participants discussed the ways in which federal investments in biomedical research are translated into innovative therapies and considered approaches to ensure that the public has affordable access to the resulting new drugs. This publication summarizes the presentations and discussions from the workshop. |
| celgene risk management survey: Rare Diseases and Orphan Products Institute of Medicine, Board on Health Sciences Policy, Committee on Accelerating Rare Diseases Research and Orphan Product Development, 2011-04-03 Rare diseases collectively affect millions of Americans of all ages, but developing drugs and medical devices to prevent, diagnose, and treat these conditions is challenging. The Institute of Medicine (IOM) recommends implementing an integrated national strategy to promote rare diseases research and product development. |
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| celgene risk management survey: Mild to Moderate Psoriasis John Y. M. Koo, Ethan C. Levin, Argentina Leon, Jashin J. Wu, Mark G. Lebwohl, 2014-03-18 Using a practical and problem-focused approach, this updated, full-color Third Edition of Mild-to-Moderate Psoriasis equips dermatologists, internists, family practitioners, and residents with a state-of-the-art guide to the clinical management of mild-to-moderate psoriasis.Written by an international team of key opinion leaders, this resource explores new developments in treatments for the condition and provides clinicians with up-to-date strategies for optimal patient management. |
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| celgene risk management survey: Quality Risk Management in the FDA-Regulated Industry José Rodríguez-Pérez, 2017-02-21 The purpose of this new edition is to offer an updated view of the risk management field as it applies to medical products. Since the publication of the first edition (2012), the emphasis on risk-based processes has growth exponentially across all sectors, and risk management is now considered as significant as quality management. ISO 9001 was revised and now requires that top management promote the use of risk-based thinking. ISO 13485:2016, which specifies the requirements for a quality management system specific to the medical devices industry, also now shows a greater emphasis on risk management and risk-based decision making. In addition, the FDA Food Safety Modernization Act (FSMA) is the most important reform of U.S. food safety laws in more than 70 years. This indispensable book presents a systematic and comprehensive approach to quality risk management. It will assist medical and food product manufacturers with the integration of a risk management system or risk management principles and activities into their existing quality management system by providing practical explanations and examples. The appropriate use of quality risk management can facilitate compliance with regulatory requirements such as good manufacturing practice or good laboratory practice. All chapters have been updated and revised, and a new chapter has been added to discuss some of the most common pitfalls and misunderstandings regarding risk management, specifically those related to the use of FMEA as the only element of risk management programs. One of the appendices includes 12 case studies, and the companion CD-ROM contains dozens of U.S. FDA and European guidance documents as well as international harmonization documents (ICH and GHTF-IMDRF) related to risk management activities, as well as a 30-question exam (with answers) on the material discussed in the book. |
| celgene risk management survey: Global Report on Psoriasis World Health Organization, 2016-02-15 This WHO Global report on psoriasis brings the public health impact of psoriasis into focus. The report is written to help raise awareness of the range of ways that psoriasis can affect peoples' lives. It intends to empower policy-makers with practical solutions to improve the health care and social inclusion of people living with psoriasis in their populations. The report highlights that much of the suffering caused by this common and complex disease can be avoided. Improving access to early diagnosis and appropriate treatment for psoriasis requires universally accessible health-care systems that provide people-centered care for patients with complex, lifelong conditions. Governments also have a key role to play in seeking to address the unnecessary social consequences of psoriasis by the challenging the myths and behaviors that lead to the exclusion of patients from healthcare settings and daily life. |
| celgene risk management survey: Highlights of Progress in Research on Cancer , 1957 |
| celgene risk management survey: National Statement on Ethical Conduct in Human Research 2023 National Health and Medical Research Council (Australia), Australian Research Council, Universities Australia, 2023 The purpose of the National Statement is to promote ethically good human research. Fulfilment of this purpose requires that participants be accorded the respect and protection that is due to them. It also involves the fostering of research that is of benefit to the community. The National Statement is therefore designed to clarify the responsibilities of: institutions and researchers for the ethical design, conduct and dissemination of results of human research ; and review bodies in the ethics review of research. The National Statement will help them to meet their responsibilities: to identify issues of ethics that arise in the design, review and conduct of human research, to deliberate about those ethical issues, and to justify decisions about them--Page 6. |
| celgene risk management survey: Making Medicines Affordable National Academies of Sciences, Engineering, and Medicine, Health and Medicine Division, Board on Health Care Services, Committee on Ensuring Patient Access to Affordable Drug Therapies, 2018-03-01 Thanks to remarkable advances in modern health care attributable to science, engineering, and medicine, it is now possible to cure or manage illnesses that were long deemed untreatable. At the same time, however, the United States is facing the vexing challenge of a seemingly uncontrolled rise in the cost of health care. Total medical expenditures are rapidly approaching 20 percent of the gross domestic product and are crowding out other priorities of national importance. The use of increasingly expensive prescription drugs is a significant part of this problem, making the cost of biopharmaceuticals a serious national concern with broad political implications. Especially with the highly visible and very large price increases for prescription drugs that have occurred in recent years, finding a way to make prescription medicinesâ€and health care at largeâ€more affordable for everyone has become a socioeconomic imperative. Affordability is a complex function of factors, including not just the prices of the drugs themselves, but also the details of an individual's insurance coverage and the number of medical conditions that an individual or family confronts. Therefore, any solution to the affordability issue will require considering all of these factors together. The current high and increasing costs of prescription drugsâ€coupled with the broader trends in overall health care costsâ€is unsustainable to society as a whole. Making Medicines Affordable examines patient access to affordable and effective therapies, with emphasis on drug pricing, inflation in the cost of drugs, and insurance design. This report explores structural and policy factors influencing drug pricing, drug access programs, the emerging role of comparative effectiveness assessments in payment policies, changing finances of medical practice with regard to drug costs and reimbursement, and measures to prevent drug shortages and foster continued innovation in drug development. It makes recommendations for policy actions that could address drug price trends, improve patient access to affordable and effective treatments, and encourage innovations that address significant needs in health care. |
| celgene risk management survey: Chronic Graft Versus Host Disease Georgia B. Vogelsang, Steven Z. Pavletic, 2009-04-20 Chronic graft versus host disease (GVHD) is the most common complication of allogenic bone marrow transplantation. Because of the protracted clinical course of chronic GVHD, transplant centers and hematology/oncology offices are inadequately equipped to manage these immuno-incompetent patients with a multi-system disorder. Practitioners need to be able to recognize and effectively manage chronic GVHD as a late effect of more than half of allogenic transplantations. The text is oriented for the clinician, with chapters covering staging, organ site and system-specific manifestations, treatment options, and supportive care. Drs Georgia B. Vogelsang and Steven Z. Pavletic have been pioneers in the recognition of the multi-organ complexity of this disease and have gathered the input of a variety of subspecialist physicians for this book. This book fills the gap in practical literature on chronic GVHD, providing a comprehensive, up-to-date, and clinically relevant resource for anyone who deals with cancer patients post-transplant. |
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| celgene risk management survey: Myeloproliferative Neoplasms Tiziano Barbui, Ayalew Tefferi, 2012-02-03 This book focuses on three of the main categories of myeloproliferative neoplasm: polycythemia vera, essential thrombocythemia, and primary myelofibrosis. Relevant laboratory and clinical advances are comprehensively covered, and great emphasis is placed on the practical issues that challenge physicians in their daily practice. The main topics considered thus include contemporary diagnostic approaches, the value and limitations of mutation screening for diagnostic and prognostic purposes, risk stratification in terms of both survival and other disease complications such as leukemic transformation and thrombosis, and modern therapeutic strategies, including conventional drugs, allogeneic stem cell transplantation, and experimental drugs still under study. The reader will find Critical Concepts and Management Recommendations in Myeloproliferative Neoplasms to be an invaluable and up-to-date source of information from leading authorities in the field. |
| celgene risk management survey: Bartlett's Medical Management of HIV Infection John G. Bartlett, Robert R. Redfield Jr., Paul A. Pham, 2019-03-22 THE PIONEERING WORK IN HIV MEDICINE, COMPLETELY REVISED FOR THE FIRST TIME SINCE 2012 The 17th edition of Bartlett's Medical Management of HIV Infection offers the best-available clinical guidance for treatment of patients with HIV. Edited by preeminent and pioneering authorities in HIV research and clinical care, it has earned its status as the definitive work for physicians, physician assistants, nurse practitioners, pharmacists, and anyone working in the care of persons with HIV. Updated to reflect the most recent innovations in HIV prevention and therapy, this text balances new and old approaches to produce a guide to clinical management in any setting. Coverage includes: · New approaches to prevention of HIV and prevention of infection in patients with HIV · Laboratory protocols for screening and treatment · Antiretroviral therapies (including dosage and adverse effects and drug interactions ) · HIV treatment in resource-limited settings · Management of infections A portable, navigable guide to an exquisitely complex field, Bartlett's Medical Management of HIV Infection is the continuing standard for practice and education in the field of HIV. |
| celgene risk management survey: Practical Geriatric Oncology Arti Hurria, Harvey Jay Cohen, 2010-09-13 The risk of cancer increases with age, and the number of older adults seeking treatment is increasing dramatically in line with the aging population. The care of older patients differs from that of younger adults because of differences in the biology of the tumor, age-related differences in host physiology, comorbidity burden and psychosocial issues, which might impact the efficacy and side effects of cancer therapy. Practical Geriatric Oncology is a comprehensive, evidence-based text that synthesizes the growing literature in this field and provides practical guidelines to the care of older adults with cancer. Coverage includes patient assessment, management of solid tumors and hematologic malignancies, the impact of age on the pharmacology of cancer therapy, surgical oncology and radiation oncology in the older adult, symptom management and supportive care. In addition to serving as core reading for oncologists and hematologists, the book will also be a useful work for other healthcare professionals who provide oncology care, including surgeons, radiation oncologists, palliative care doctors, primary care providers, geriatricians and nurses. |
| celgene risk management survey: Amyloidosis Morie A. Gertz, S. Vincent Rajkumar, 2010-06-14 An up-to-date reference on this fascinating set of complex disorders, this book features the most comprehensive strategies for diagnosing, classifying, imaging, treating, and managing amyloidosis in multiple organ systems. Beneficial to the spectrum of practitioners from residents to sub-specialists, this book is a succinct authoritative text written by leaders in the field. The authors provide instruction on all forms of amyloidosis - including primary amyloidosis (AL), secondary amyloidosis (AA), and familial amyloidosis. With essential treatment algorithms, Amyloidosis: Diagnosis and Treatment is the gold-standard for all hematologists, oncologists, and internists caring for patients with this complex disease. |
| celgene risk management survey: The Surgeon General's Call to Action to Prevent Skin Cancer Office of Office of the Surgeon, U.S. Department of Health and Human Services, 2019-07-27 This document is a Call to Action to partners in prevention from various sectors across the nation to address skin cancer as a major public health problem. Many partners are essential to this effort, including federal, state, tribal, local, and territorial governments; members of the business, health care, and education sectors; community, nonprofit, and faith-based organizations; and individuals and families. The goal of this document is to increase awareness of skin cancer and to call for actions to reduce its risk.The first section describes the problem of skin cancer and its major risk factors. It also discusses the relationship between exposure to ultraviolet (UV) radiation and health. The second section describes the current evidence on preventing skin cancer, including current initiatives in the United States and in other countries. The third section describes the gaps in research related to skin cancer prevention, highlighting areas of research where more work is needed. The fourth section identifies specific opportunities to prevent skin cancer by reducing UV exposure in the U.S. population and calls for nationwide action. |
| celgene risk management survey: Continuous Renal Replacement Therapy John A. Kellum, Rinaldo Bellomo, Claudio Ronco, 2016 Continuous Renal Replacement Therapy provides concise, evidence-based, bedside guidance for the management of critically ill patients with acute renal failure, offering quick reference answers to clinicians' questions about treatments and situations encountered in daily practice. |
| celgene risk management survey: Chimeric Antigen Receptor T-Cell Therapies for Cancer E-Book Daniel W. Lee, Nirali N. Shah, 2019-11-30 From patient referral to post-therapy management, Chimeric Antigen Receptor (CAR) T-Cell Therapies for Cancer: A Practical Guide presents a comprehensive view of CAR modified T-cells in a concise and practical format. Providing authoritative guidance on the implementation and management of CAR T-cell therapy from Drs. Daniel W. Lee and Nirali N. Shah, this clinical resource keeps you up to date on the latest developments in this rapidly evolving area. - Covers all clinical aspects, including patient referral, toxicities management, comorbidities, bridging therapy, post-CAR monitoring, and multidisciplinary approaches to supportive care. - Includes key topics on associated toxicities such as predictive biomarkers, infections, and multidisciplinary approaches to supportive care. - Presents current knowledge on FDA approved CAR T-cell products as well as developments on the horizon. - Editors and authors represent leading investigators in academia and worldwide pioneers of CAR therapy. |
| celgene risk management survey: Moderate to Severe Psoriasis John Koo, Jashin Wu, Alice Gottlieb, Ethan Levin, Argentina Leon, 2014-03-18 Written by experts in the dermatology field, this new fourth edition of Moderate-to-Severe Psoriasis discusses the current use of biologics and other pharmacologic and phototherapy treatments for moderate-to-severe psoriasis. Illustrated with high quality color figures, this standalone text emphasizes safe and effective treatments for the psoriasis |
| celgene risk management survey: Psoriasis: Contemporary and Future Therapies, An Issue of Dermatologic Clinics, E-Book Jeffrey M. Cohen, 2024-05-28 In this issue of Dermatologic Clinics, guest editor Dr. Jeffrey M. Cohen brings his considerable expertise to the topic of Psoriasis: Contemporary and Future Therapies. Top experts in the field discuss oral therapies for psoriasis; phototherapy for psoriasis in the era of biologics; the psoriasis treatment pipeline; psoriasis comorbidities and their impact on treatment; underdiagnosis and undertreatment of traditional cardiovascular risk factors in psoriasis; and much more. - Contains 14 relevant, practice-oriented topics including biologics for psoriasis; psoriasis genetics and the impact of genetics on comorbidities and treatment; psoriasis therapies in the pediatric population; disparities in psoriasis treatment; immune checkpoint inhibitor-induced psoriasis; and more. - Provides in-depth clinical reviews on psoriasis: contemporary and future therapies, offering actionable insights for clinical practice. - Presents the latest information on this timely, focused topic under the leadership of experienced editors in the field. Authors synthesize and distill the latest research and practice guidelines to create clinically significant, topic-based reviews. |
| celgene risk management survey: Cancer and Aging M. Extermann, 2013-01-18 Cancer is clearly an age-related disease. Recent research in both aging and cancer has demonstrated the complex interaction between the two phenomena. This affects a wide spectrum of research and practice, anywhere from basic research to health care organization. Core examples of these close associations are addressed in this book. Starting with basic research, the first chapters cover cancer development, mTOR inhibition, senescent cells altering the tumor microenvironment, and immune senescence affecting cancer vaccine response. Taking into account the multidisciplinarity of geriatric oncology, several chapters focus on geriatric and oncologic aspects in patient assessment, treatment options, nursing and exercise programs. The book is rounded off by a discussion on the impact of the metabolic syndrome illustrating the interactions between comorbidity and cancer and a chapter on frailty.This book provides the reader with insights that will hopefully foster his or her reflection in their own research and practice to further the development of this most exciting field. Given the aging of the population worldwide and the high prevalence of cancer, it is essential reading not only for oncologists and geriatricians but for all health practitioners. |
| celgene risk management survey: Drug Safety Evaluation Shayne Cox Gad, Dexter W. Sullivan, Jr., 2023-01-12 Drug Safety Evluation Comprehensive and practical guide presenting a roadmap for safety assessment as an integral part of the development of drugs and therapeutics This fourth edition of Drug Safety Evaluation maintains the central objective of presenting an all-inclusive practical guide for those who are responsible for ensuring the safety of drugs and biologics to patients, healthcare providers, those involved in the manufacture of medicinal products, and all those who need to understand how the safety of these products is evaluated and shepherding valuable candidates to market. Individual chapters address specific approaches to evaluation hazards, including problems that are encountered and their solutions. Also covered are the scientific and philosophical bases for evaluation of specific concerns (e.g., carcinogenicity, development toxicity, etc.) to provide both understanding and guidance for approaching the new problems that have come to face both our society and the new challenges they brought. The many changes in regulatory requirements, pharmaceutical development, technology, and the effects of Covid on our society and science have required both extensive revision to every chapter and the addition of four new chapters. Specific sample topics covered in Drug Safety Evaluation include: The drug development process and the global pharmaceutical marketplace and regulation of human pharmaceutical safety Sources of information for consideration in study and program design and in safety evaluation Electronic records, reporting and submission, screens in safety and hazard assessment, and formulations, routes, and dosage regimens Mechanisms and endpoints of drug toxicity, pilot toxicity testing in drug safety evaluation, and repeat dose toxicity Genotoxicity, QSAR tools for drug safety, toxicogenomics, nonrodent animal studies, and developmental and reproductive toxicity testing An appendix which provides an up to date guide to CROs for conducting studies Drug Safety Evaluation was written specifically for the pharmaceutical and biotechnology industries, including scientists, consultants, and academics, to show a utilitarian yet scientifically valid path to the everyday challenges of safety evaluation and the problem solving that is required in drug discovery and development. |
| celgene risk management survey: Cannabis as Medicine Betty Wedman-St.Louis, 2019-09-26 For hundreds of years cannabis has been used as a therapeutic medicine around the world. Cannabis was an accepted medicine during the second half of the 19th century, but its use declined because single agent pain medications were advocated by physicians who demanded standardization of medicines. It was not until 1964 when the chemical structure of THC (delta 9-tetrahydrocannabinol) was elucidated and its pharmacological effects began to be understood. Numerous therapeutic effects of cannabis have been reviewed, but cannabis-based medicines are still an enigma because of legal issues. Many patients could benefit from cannabinoids, terpenoids and flavonoids found in Cannabis sativa L. These patients suffer from medical conditions including chronic pain, chronic inflammatory diseases, neurological disorders, and other debilitating illnesses. As more states are legalizing medical cannabis, prescribers need a reliable source which provides clinical information in a succinct format. This book focuses on the science of cannabis as an antioxidant and anti-inflammatory supplement. It discusses cannabis uses in the human body for bone health/osteoporosis; brain injury and trauma; cancer; diabetes; gastrointestinal conditions; mental health disorders; insomnia; pain; anxiety disorders; depression; migraines; eye disorders; and arthritis and inflammation. There is emphasis on using the whole plant — from root to raw leaves and flowers discussing strains, extraction and analysis, and use of cannabis-infused edibles. Features: Provides an understanding of the botanical and biochemistry behind cannabis as well as its use as a dietary supplement. Discusses endocannabinoid system and cannabinoid receptors. Includes information on antioxidant benefits, pain receptors using cannabinoids, and dosage guidelines. Presents research on cannabis treatment plans, drug-cannabis interactions and dosing issues, cannabis vapes, edibles, creams, and suppositories. Multiple appendices including a glossary of cannabis vocabulary, how to use cannabis products, a patient guide and recipes as well as information on cannabis for pets. |
| celgene risk management survey: The EBMT Handbook Nicolaus Kröger, Mohamad Mohty, Carlo Dufour, 2020-10-08 This Open Access edition of the European Society for Blood and Marrow Transplantation (EBMT) handbook addresses the latest developments and innovations in hematopoietic stem cell transplantation and cellular therapy. Consisting of 93 chapters, it has been written by 175 leading experts in the field. Discussing all types of stem cell and bone marrow transplantation, including haplo-identical stem cell and cord blood transplantation, it also covers the indications for transplantation, the management of early and late complications as well as the new and rapidly evolving field of cellular therapies. This book provides an unparalleled description of current practices to enhance readers' knowledge and practice skills. This work was published by Saint Philip Street Press pursuant to a Creative Commons license permitting commercial use. All rights not granted by the work's license are retained by the author or authors. |
| celgene risk management survey: Human Retrovirology William A. Blattner, 1990 |
| celgene risk management survey: SITC’s Guide to Managing Immunotherapy Toxicity Marc S. Ernstoff, MD, Igor Puzanov, MD, MSCI, FACP, Caroline Robert, MD, PhD, Adi M. Diab, MD, Peter M. Hersey, MD, PhD, 2019-03-15 The Society for Immunotherapy of Cancer's handbook,SITC’s Guide to Managing Immunotherapy Toxicity, is a practical reference to managing side effects associated with FDA-approved cancer immunotherapy drugs. Separated into two parts, Part I contains chapter-based overviews of immune checkpoint inhibitors in the clinic, starting with anti-CTLA4 agents, anti-PD1/PD-L1 agents, and approved immunotherapeutic combinations. These chapters cover relevant mechanisms of action, indications, and toxicities seen while combating early, advanced, and metastatic stages in cancer patients. Part II is structured by common and uncommon toxicities that affect major organ sites throughout the body. It begins with a general summary of principles and management options followed by chapters focusing on specific toxicities such as rash and mucosal irritation, muscle and joint toxicity, diarrhea and colitis, pneumonitis, endocrine toxicities, neurological toxicities, cardiac toxicity, renal toxicity, hematologic toxicity, and ocular toxicities. Each chapter provides guidance on how to assess and treat the toxicity and how to support the patient through acute and chronic effects with detailed summary tables for quick reference. Part II concludes with chapters covering management of special patient populations, including patients with autoimmune disease and geriatric patients, treatment and management of fatigue, and a final chapter dedicated to cost effectiveness and the toll of financial toxicity on patients and caregivers. With chapters written by world-recognized leaders in the immuno-oncology field, this text provides thorough coverage of the toxicity and management of adverse effects for immune checkpoint inhibitors. It is an indispensable resource for clinical oncologists, emergency physicians, hospitalists and other medical practitioners in both the hospital and community clinic settings, especially as the use of immune checkpoint inhibitors becomes a fixture in oncology care. Key Features: Outlines strategies for treating high-risk patients facing an acute or chronic side effect to immunotherapy Provides numerous tables that condense and highlight pertinent information for quick reference Describes the various clinical presentations and toxic reactions caused by immunotherapy Purchase includes access to the eBook for use on most mobile devices or computer |
| celgene risk management survey: Adherence in Dermatology Scott A. Davis, 2016-05-10 An essential, comprehensive, and practical guide to understanding, measuring, and modifying patients’ adherence behavior to optimize treatment outcomes, this book covers all major aspects of adherence in dermatology. The first section describes current knowledge on the magnitude and impact of nonadherence; the second outlines measuring adherence in the context of databases, trials and practice. The third section addresses adherence in key skin diseases and the fourth covers numerous strategies to improve adherence by mitigating specific patient barriers. All sections emphasize ways to optimize communication with patients: the foundation for producing successful health behavior change. Low adherence helps explain why, despite effective treatments existing for all major dermatologic conditions, many patients still fail to improve. When clinicians endeavour to maximize adherence, with the aid of evidence-based strategies, these drugs will often realise their potential. This book devotes special attention to understanding why individuals may be nonadherent, so that each patient can receive a suitable treatment regimen, with a personalized plan of action. This book is designed for clinicians at all levels, serving as both introductory training for medical students and residents, and an update on the field for experienced practitioners. Researchers and policymakers will also benefit from its coverage of research methods and the impact of nonadherence in specific diseases. Adherence in Dermatology bridges the gap between outcomes researchers and clinicians by explaining the latest findings in plain language, with examples from everyday dermatologic practice. |
| celgene risk management survey: Allogeneic Stem Cell Transplantation Hillard M. Lazarus, Mary J. Laughlin, 2010-03-02 Since the original publication of Allogeneic Stem Cell Transplantation: Clinical Research and Practice, Allogeneic hematopoietic stem cell transplantation (HSC) has undergone several fast-paced changes. In this second edition, the editors have focused on topics relevant to evolving knowledge in the field in order to better guide clinicians in decision-making and management of their patients, as well as help lead laboratory investigators in new directions emanating from clinical observations. Some of the most respected clinicians and scientists in this discipline have responded to the recent advances in the field by providing state-of-the-art discussions addressing these topics in the second edition. The text covers the scope of human genomic variation, the methods of HLA typing and interpretation of high-resolution HLA results. Comprehensive and up-to-date, Allogeneic Stem Cell Transplantation: Clinical Research and Practice, Second Edition offers concise advice on today's best clinical practice and will be of significant benefit to all clinicians and researchers in allogeneic HSC transplantation. |
| celgene risk management survey: Early Rheumatoid Arthritis Paul Emery, 2005 This issue covers the latest developments in the understanding of rheumatoid arthritis at the early stage. Treatments such as with newer biologic agents and conventional disease-modifying antirheumatic drugs are reviewed. Also included are articles on imaging modalities as a means of identifying those in the early stages and monitoring response to treatment. |
| celgene risk management survey: Antifungal Therapy Mahmoud Ghannoum, John R. Perfect, 2016-04-19 A concise one-stop-practical reference for the various physicians dealing with fungal infections, Antifungal Therapy appeals to infectious disease physicians, transplant surgeons, dermatologists, and intensivists, as well as basic scientists and pharmaceutical company researchers interested in the state of antifungal therapy. This book provides a c |
| celgene risk management survey: Burnout for Experts Sabine Bährer-Kohler, 2012-11-11 Wherever people are working, there is some type of stress—and where there is stress, there is the risk of burnout. It is widespread, the subject of numerous studies in the U.S. and abroad. It is also costly, both to individuals in the form of sick days, lost wages, and emotional exhaustion, and to the workplace in terms of the bottom line. But as we are now beginning to understand, burnout is also preventable. Burnout for Experts brings multifaceted analysis to a multilayered problem, offering comprehensive discussion of contributing factors, classic and less widely perceived markers of burnout, coping strategies, and treatment methods. International perspectives consider phase models of burnout and differentiate between burnout and related physical and mental health conditions. By focusing on specific job and life variables including workplace culture and gender aspects, contributors give professionals ample means for recognizing burnout as well as its warning signs. Chapters on prevention and intervention detail effective programs that can be implemented at the individual and organizational levels. Included in the coverage: · History of burnout: a phenomenon. · Personal and external factors contributing to burnout. · Depression and burnout · Assessment tools and methods. · The role of communication in burnout prevention. · Active coping and other intervention strategies. Skillfully balancing scholarship and accessibility, Burnout for Experts is a go-to resource for health psychologists, social workers, psychiatrists, and organizational, industrial, and clinical psychologists. |
| celgene risk management survey: The selection and use of essential medicines , 2022-01-26 The 23rd meeting of the WHO Expert Committee on Selection and Use of Essential Medicines was coordinated from Geneva, Switzerland, and held virtually from 21 June to 2 July 2021. The Committee considered 88 applications proposing additions, changes and deletions of medicines, medicine classes and formulation on the Model Lists of Essential Medicines. The Committee evaluated the scientific evidence for comparative effectiveness, safety and cost-effectiveness of the medicines in question. The Committee also considered a review of the therapeutic alternatives for medicines on the Model Lists, and update to the AWaRe classification of antibiotics, and reviews and reports relevant to the selection and use of essential medicines. |
| celgene risk management survey: Sex and Gender Aspects in Clinical Medicine Sabine Oertelt-Prigione, Vera Regitz-Zagrosek, 2011-11-15 This book is a concise, easy to read professional text with a focus on practical aspects. All chapters include tables on sex/gender differences in symptoms and management and a series of suggestions to the novice in the field. Chapters are specialty-specific. The focus is not on women’s health, but the presentation of differences in clinical symptoms, management and outcomes in women and men. Gender Medicine strives to employ the knowledge about these differences to improve diagnosis, better understand pathogenesis and advance patient-oriented therapy. |
| celgene risk management survey: Registries for Evaluating Patient Outcomes Agency for Healthcare Research and Quality/AHRQ, 2014-04-01 This User’s Guide is intended to support the design, implementation, analysis, interpretation, and quality evaluation of registries created to increase understanding of patient outcomes. For the purposes of this guide, a patient registry is an organized system that uses observational study methods to collect uniform data (clinical and other) to evaluate specified outcomes for a population defined by a particular disease, condition, or exposure, and that serves one or more predetermined scientific, clinical, or policy purposes. A registry database is a file (or files) derived from the registry. Although registries can serve many purposes, this guide focuses on registries created for one or more of the following purposes: to describe the natural history of disease, to determine clinical effectiveness or cost-effectiveness of health care products and services, to measure or monitor safety and harm, and/or to measure quality of care. Registries are classified according to how their populations are defined. For example, product registries include patients who have been exposed to biopharmaceutical products or medical devices. Health services registries consist of patients who have had a common procedure, clinical encounter, or hospitalization. Disease or condition registries are defined by patients having the same diagnosis, such as cystic fibrosis or heart failure. The User’s Guide was created by researchers affiliated with AHRQ’s Effective Health Care Program, particularly those who participated in AHRQ’s DEcIDE (Developing Evidence to Inform Decisions About Effectiveness) program. Chapters were subject to multiple internal and external independent reviews. |
| celgene risk management survey: Dying in America Institute of Medicine, Committee on Approaching Death: Addressing Key End-of-Life Issues, 2015-03-19 For patients and their loved ones, no care decisions are more profound than those made near the end of life. Unfortunately, the experience of dying in the United States is often characterized by fragmented care, inadequate treatment of distressing symptoms, frequent transitions among care settings, and enormous care responsibilities for families. According to this report, the current health care system of rendering more intensive services than are necessary and desired by patients, and the lack of coordination among programs increases risks to patients and creates avoidable burdens on them and their families. Dying in America is a study of the current state of health care for persons of all ages who are nearing the end of life. Death is not a strictly medical event. Ideally, health care for those nearing the end of life harmonizes with social, psychological, and spiritual support. All people with advanced illnesses who may be approaching the end of life are entitled to access to high-quality, compassionate, evidence-based care, consistent with their wishes. Dying in America evaluates strategies to integrate care into a person- and family-centered, team-based framework, and makes recommendations to create a system that coordinates care and supports and respects the choices of patients and their families. The findings and recommendations of this report will address the needs of patients and their families and assist policy makers, clinicians and their educational and credentialing bodies, leaders of health care delivery and financing organizations, researchers, public and private funders, religious and community leaders, advocates of better care, journalists, and the public to provide the best care possible for people nearing the end of life. |
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