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Pharmacovigilance A Practical Approach

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Pharmacovigilance A Practical Approach

Pharmacovigilance  A Practical Approach Book
Author : Thao Doan,Cheryl Renz,Fabio Lievano,Mondira Bhattacharya,Linda Scarazzini
Publisher : Elsevier Health Sciences
Release : 2018-07-31
ISBN : 032358117X
Language : En, Es, Fr & De

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Book Description :

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.

The Role of the Pharmacist in Patient Care

The Role of the Pharmacist in Patient Care Book
Author : Abdul Kader Mohiuddin
Publisher : Universal-Publishers
Release : 2020
ISBN : 1627343083
Language : En, Es, Fr & De

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Book Description :

The goal of a high quality, cost-effective and accessible health care for patients is achieved through constructing a team-based and patient-centered health care delivery system. The expanded role of pharmacists uplifts them to patient care from dispensing and manufacturing or marketing of drugs. Along with doctors and allied health professionals, pharmacists are increasingly recognized as an integral part of the patient care team. Furthermore, colleges of pharmacy need to revise and up-date their curricula to accommodate the progressively increasing development in the pharmaceutical education and the evolving new roles of practicing pharmacists in patient care settings. This book focuses on the expanded role of the pharmacists in total patient care including prescribing, dispensing, compounding, administering and monitoring of drugs at home, hospital, community, hospice, critical care, changeover and other care settings. The sector is emerging in both developed and under-developed countries. Overburdened by patient loads and the explosion of new drugs physicians turned to pharmacists more and more for drug information especially within institutional settings. And today’s patient care pharmacists are taking more interests in medication review and reconciliation, patient education and counseling, creating drug therapy regimen and monitoring compliance. The purpose of this book is to guide the pharmacists in their daily interactions with patients and to ensure collaboration with other health professionals. The contents are mostly based on recently published articles related to patient care, with most recent ideas and activities followed by the patient care pharmacists around the globe. However, a pharmacist implements the care plan in collaboration with other health care professionals and the patient or caregiver. Along with professional guidelines, the book discusses the concepts and best practices of patient interaction, patient rights, and ethical decision-making for the professional pharmacist, apprentice and student. In every chapter, the role of pharmacists in that chapter specific issues are detailed explicitly so that a professional pharmacist or a student can figure out his or her do’s and don’ts in that specific situation. Moreover, further reading references are listed as future recommendations. So, the book is an archive of potential references too. Among so many books about patient care, either doctors’ or nurses’ roles are highlighted. The proposed book highlights the pharmacists’ roles and responsibilities to the most, separated from those of doctors and nurses, with the most recent information obtained from most publications in several journals, books, bulletins, newsletter, magazines etc.

A Practical Handbook on the Pharmacovigilance of Antimalarial Medicines

A Practical Handbook on the Pharmacovigilance of Antimalarial Medicines Book
Author : World Health Organization
Publisher : World Health Organization
Release : 2008
ISBN : 9241547499
Language : En, Es, Fr & De

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Book Description :

The Handbook is a detailed manual giving a step by step approach to undertaking the pharmacovigilance of antimalarials. It is intended to be a source of practical advice for pharmacovigilance centres. It provides information on spontaneous reporting of adverse drug reactions as a complement to other WHO publications. In addition, it provides details on how to conduct cohort event monitoring, which is a method of active safety surveillance collecting information on all adverse events occurring after treatment. It also details how to perform causality assessment and signal identification, applicable to both methods of surveillance.

A Practical Approach to Pharmaceutical Policy

A Practical Approach to Pharmaceutical Policy Book
Author : Andreas Seiter
Publisher : World Bank Publications
Release : 2010-06-17
ISBN : 9780821383872
Language : En, Es, Fr & De

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Book Description :

This book offers policy makers a hands-on approach, tested in the World Bank’s field work in many countries, for developing policies that improve access to safe, effective medicines in health systems of low- and middle-income economies.

Drug Safety in Developing Countries

Drug Safety in Developing Countries Book
Author : Yaser Mohammed Al-Worafi
Publisher : Academic Press
Release : 2020-06-03
ISBN : 0128204125
Language : En, Es, Fr & De

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Book Description :

Drug Safety in Developing Countries: Achievements and Challenges provides comprehensive information on drug safety issues in developing countries. Drug safety practice in developing countries varies substantially from country to country. This can lead to a rise in adverse reactions and a lack of reporting can exasperate the situation and lead to negative medical outcomes. This book documents the history and development of drug safety systems, pharmacovigilance centers and activities in developing countries, describing their current situation and achievements of drug safety practice. Further, using extensive case studies, the book addresses the challenges of drug safety in developing countries. Provides a single resource for educators, professionals, researchers, policymakers, organizations and other readers with comprehensive information and a guide on drug safety related issues Describes current achievements of drug safety practice in developing countries Addresses the challenges of drug safety in developing countries Provides recommendations, including practical ways to implement strategies and overcome challenges surrounding drug safety

Trends and Innovations in Information Systems and Technologies

Trends and Innovations in Information Systems and Technologies Book
Author : Álvaro Rocha,Hojjat Adeli,Luís Paulo Reis,Sandra Costanzo,Irena Orovic,Fernando Moreira
Publisher : Springer Nature
Release : 2020-05-17
ISBN : 3030456978
Language : En, Es, Fr & De

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Book Description :

This book gathers selected papers presented at the 2020 World Conference on Information Systems and Technologies (WorldCIST’20), held in Budva, Montenegro, from April 7 to 10, 2020. WorldCIST provides a global forum for researchers and practitioners to present and discuss recent results and innovations, current trends, professional experiences with and challenges regarding various aspects of modern information systems and technologies. The main topics covered are A) Information and Knowledge Management; B) Organizational Models and Information Systems; C) Software and Systems Modeling; D) Software Systems, Architectures, Applications and Tools; E) Multimedia Systems and Applications; F) Computer Networks, Mobility and Pervasive Systems; G) Intelligent and Decision Support Systems; H) Big Data Analytics and Applications; I) Human–Computer Interaction; J) Ethics, Computers & Security; K) Health Informatics; L) Information Technologies in Education; M) Information Technologies in Radiocommunications; and N) Technologies for Biomedical Applications.

A Practical Handbook on the Pharmacovigilance of Antiretroviral Medicines

A Practical Handbook on the Pharmacovigilance of Antiretroviral Medicines Book
Author : World Health Organization
Publisher : World Health Organization
Release : 2009
ISBN : 9241547944
Language : En, Es, Fr & De

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Book Description :

This is a detailed manual giving a step-by-step approach to undertaking the pharmacovigilance of antiretrovirals. It is intended to be a source of practical advice for Pharmacovigilance Centres and health professionals involved in HIV/AIDS prevention and treatment programs. There is an urgent need to develop robust pharmacovigilance systems for antiretrovirals particularly in resource-limited settings. This detailed manual gives a step by step approach to undertaking the pharmacovigilance of these medicines. Good pharmacovigilance will identify the risks in the shortest possible time after the medicine has been marketed and will help to establish/identify risk factors. This manual describes the principles of both spontaneous reporting systems and cohort event monitoring programs. It is intended to be a source of practical advice for Pharmacovigilance Centres and health professionals involved in HIV/AIDS programs.

Phage Therapy A Practical Approach

Phage Therapy  A Practical Approach Book
Author : Andrzej Górski,Ryszard Międzybrodzki,Jan Borysowski
Publisher : Springer Nature
Release : 2019-10-25
ISBN : 3030267369
Language : En, Es, Fr & De

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Book Description :

This book gives a detailed yet clear insight into the current state of the art of the therapeutic application of bacteriophages in different conditions. The authors bring in their practical expertise within their respective fields of expertise and provide an excellent overview of the potential and actual use of phage therapy. Topics like economic feasibility compared to traditional antibiotics and also regulatory issues are discussed in far detail. This new volume is therefore a valuable resource for individuals engaged in the medical application of novel phage therapies.

Clinical Psychopharmacology

Clinical Psychopharmacology Book
Author : Humberto Marin,Javier I Escobar
Publisher : World Scientific
Release : 2013-08-19
ISBN : 9814578371
Language : En, Es, Fr & De

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Book Description :

This book aims to provide comprehensive, up-to-date information on psychotropic drugs and inform clinical decisions for the treatment of mental disorders using a problem-solving approach. In order to accomplish these goals, the book has three central characteristics: it is evidence-basedit compares each individual drug with others in the same class and also those used for the same indications rather than describing them separatelyit steadily draws practical conclusions and makes recommendations about how to select and use medications in the treatment of specific mental disorders More than a textbook, it is meant to serve as a practical tool for professionals working in the mental health field. Contents:Absorption, Transformation, and Elimination of Psychotropic MedicationsNeurotransmitters, Receptors, and TransportersAntipsychotics: A General View of Therapeutic and Adverse EffectsDescription of Individual AntipsychoticsTreatment of Schizophrenia with Antipsychotic MedicationsAntidepressants: Selective Serotonin Reuptake Inhibitors and Serotonin–Norepinephrine Reuptake InhibitorsBupropionMirtazapine, Trazodone, and NefazodoneMonoamine Oxidase Inhibitors and Tricyclic AntidepressantsIndividualized Treatment of DepressionBenzodiazepines, Buspirone, and Miscellaneous Medications Used in Anxiety DisordersMedication Treatment of Anxiety DisordersMedications Used in the Treatment of ManiaMedications Used in Bipolar Depression, Mixed States, and Rapid CyclingMedications Used in the Treatment of InsomniaMedications Used in the Treatment of Attention DisordersMedications Used in the Treatment of DementiaMedications Used in Smoking Cessation and Alcohol Use DisordersDrug–Drug Interactions Readership: Professional psychiatrists, psychologists, primary care practitioners, clinical practitioners. Key Features:Practical pointers to help with day to day “real world” situations encountered in practiceBrief, practical chapters written in a simple, friendly language generally avoiding jargon and excessive theorizingKeywords:Psychopharmacology;Evidence-Based Treatments;Primary Care Psychiatry;Outpatient Psychiatry

A Practical Approach to Movement Disorders

A Practical Approach to Movement Disorders Book
Author : Hubert H. Fernandez, MD,Benjamin Lee Walter, MD,Taylor Rush, PhD,Anwar Ahmed, MD
Publisher : Springer Publishing Company
Release : 2021-08-04
ISBN : 0826146597
Language : En, Es, Fr & De

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Book Description :

Revised Third Edition of the practical yet authoritative guide to diagnosis and treatment of movement disorders. Written in an expanded outline format, this book is packed with flow charts, algorithms, and tables to provide quick access to point-of-care information. Easy-to-read and thoroughly up-to-date, this new edition includes the latest diagnostic and treatment protocols, recent FDA-approved drugs, and non-pharmacological therapies. With coverage of all major disease categories, this essential handbook belongs in the pocket of any clinician who suspects a movement disorder in a patient. The book is organized by medical, behavioral, surgical, and non-pharmacological treatment approaches to movement disorders. Opening chapters walk the practitioner through clinical presentation, diagnosis, and work-up of common and uncommon disorders, sleep-related movement disorders, eye and vestibular function, including pediatric issues. Behavioral and psychiatric complications for Parkinson disease, Huntington disease, and Tourette syndrome follow, with a fully reconfigured chapter on functional movement disorders, incorporating changes in classification and treatment approach. Expanded chapters on surgical devices and indications address deep brain stimulation surgery; lesioning, shunts, and pumps; post-operative care; and neuropsychological, social, and ethical issues. The final section on non-pharmacological approaches covers physical and occupational therapy, speech and swallowing therapy, nutrition, and palliative care. Key Features: Thoroughly revised and updated third edition of popular practical resource for busy clinicians Incorporates most recent evidence for the pharmacological, behavioral, surgical, and non-pharmacological treatment of the full spectrum of movement disorders Expanded bullet-point outline format for quick access to essential information Loaded with illustrative flow charts, algorithms, and tables outlining drug dosing, side effects, and other therapeutic treatments

Veterinary Pharmacovigilance

Veterinary Pharmacovigilance Book
Author : Kevin Woodward
Publisher : John Wiley & Sons
Release : 2009-11-24
ISBN : 9781444322941
Language : En, Es, Fr & De

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Book Description :

Veterinary Pharmacovigilance: Adverse Reactions to Veterinary Medicinal Products is an in-depth examination of veterinary pharmacovigilance, looking at the scientific methodologies involved, the role of regulatory agencies and legislation, and the underpinning science. Edited by a renowned expert with over 20 years of experience in the field, it draws together the expertise of authors from around the world.

Pharmacovigilance

Pharmacovigilance Book
Author : Ronald D. Mann,Elizabeth B. Andrews
Publisher : John Wiley & Sons
Release : 2007-02-06
ISBN : 0470059222
Language : En, Es, Fr & De

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Book Description :

Written by an international team of outstanding editors and contributors, Pharmacovigilance, 2nd Edition is the definitive text on this important subject. The new edition has been completely revised and updated to include the latest theoretical and practical aspects of pharmacovigilance including legal issues, drug regulatory requirements, methods of signal generation, reporting schemes and pharmacovigilance in selected system-organ classes. . The editors and contributors are of excellent standing within the pharmacovigilance community The text provides exemplary coverage of all the relevant issues The definitive book on the subject

A Practical Handbook on the Pharmacovigilance of Medicines Used in the Treatment of Tuberculosis

A Practical Handbook on the Pharmacovigilance of Medicines Used in the Treatment of Tuberculosis Book
Author : Anonim
Publisher : Unknown
Release : 2012
ISBN : 9789241503495
Language : En, Es, Fr & De

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Book Description :

Most of the medicines used to treat tuberculosis (TB) today have been on the market for several decades. Clinicians treating TB patients around the world know these medicines well, and are usually well aware of their associated adverse drug reactions (ADRs). The occurrence of these reactions is known to be frequent. The TB patient on treatment is taking more than one anti-TB medicine simultaneously and regimens last from many months to 2 years or more. This increases the likelihood of ADRs, some of which are severe. Most patients on treatment for drug-resistant TB experience at least one side-effect, and a recent study has shown that two thirds of such patients have had at least one medicine stopped temporarily or permanently as a result of ADRs. These events may damage public confidence in any national treatment programme and affect patient adherence. Patients who stop taking anti-TB medicines pose a risk to themselves and to others. The generation of drug resistance is a very real risk. So why should TB practitioners today reflect on a more systematic approach to surveillance of drug-related problems, which is at the heart of pharmacovigilance? Firstly, while national TB programmes are generally well structured to monitor patients and have a long tradition of following up care using standardized indicators, they do not collect information on ADRs directly. It is therefore difficult to assess precisely the net benefit of a treatment programme if adversities related to the medicines used are not factored in. The contribution of ADRs to death, treatment default and failure can therefore only be conjectured. Secondly, the widespread recognition by health workers that anti-TB medicines often cause ADRs is poorly reflected in the published information on the subject. There is a dearth of published literature about anti-TB drug-induced mortality, morbidity and reduced quality of life, particularly in low-resource settings. The overall burden of adversity directly attributable to anti-TB medicines is poorly quantified and it is not usually well profiled in individual TB control programmes. Thirdly, with the increasing use worldwide of more extensive regimens for drug-resistant TB, the added use of antiretrovirals (ARVs) in patients with HIV-associated TB, and the imminent advent of new classes of medicines to treat TB, the case for improved pharmacovigilance becomes even stronger. Pharmacovigilance needs to be an integral accompaniment to treatment programmes as they expand their geographical coverage, given that the frequency and expression of ADRs may be influenced by factors linked to the demographic, genetic and nutritional patterns, and to the background co-morbidity (e.g. TB/HIV) in a population. The cornerstones of pharmacovigilance apply equally to TB as to any other disease amenable to medication. Events linked to medications, particularly novel medicines or new combinations thereof, need to be recognized in a timely fashion if the events are to provide benefit to the individual patient and enrich public knowledge. Appropriate measures need to be put in place to ensure that harm is reduced and symptoms relieved. Health-care workers need to be informed and trained about the methodology and routes for reporting ADRs. This handbook aims to satisfy the need for pharmacovigilance, which has been neglected in the domain of TB for too long.

Clinical Pharmacy Education Practice and Research

Clinical Pharmacy Education  Practice and Research Book
Author : Dixon Thomas
Publisher : Elsevier
Release : 2018-11-23
ISBN : 0128142774
Language : En, Es, Fr & De

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Book Description :

Clinical Pharmacy Education, Practice and Research offers readers a solid foundation in clinical pharmacy and related sciences through contributions by 83 leading experts in the field from 25 countries. This book stresses educational approaches that empower pharmacists with patient care and research competencies. The learning objectives and writing style of the book focus on clarifying the concepts comprehensively for a pharmacist, from regular patient counseling to pharmacogenomics practice. It covers all interesting topics a pharmacist should know. This book serves as a basis to standardize and coordinate learning to practice, explaining basics and using self-learning strategies through online resources or other advanced texts. With an educational approach, it guides pharmacy students and pharmacists to learn quickly and apply. Clinical Pharmacy Education, Practice and Research provides an essential foundation for pharmacy students and pharmacists globally. Covers the core information needed for pharmacy practice courses Includes multiple case studies and practical situations with 70% focused on practical clinical pharmacology knowledge Designed for educational settings, but also useful as a refresher for advanced students and researchers

The Cellular Automaton Interpretation of Quantum Mechanics

The Cellular Automaton Interpretation of Quantum Mechanics Book
Author : Gerard 't Hooft
Publisher : Springer
Release : 2016-09-02
ISBN : 9783319412856
Language : En, Es, Fr & De

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Book Description :

This book presents the deterministic view of quantum mechanics developed by Nobel Laureate Gerard 't Hooft. Dissatisfied with the uncomfortable gaps in the way conventional quantum mechanics meshes with the classical world, 't Hooft has revived the old hidden variable ideas, but now in a much more systematic way than usual. In this, quantum mechanics is viewed as a tool rather than a theory. The author gives examples of models that are classical in essence, but can be analysed by the use of quantum techniques, and argues that even the Standard Model, together with gravitational interactions, might be viewed as a quantum mechanical approach to analysing a system that could be classical at its core. He shows how this approach, even though it is based on hidden variables, can be plausibly reconciled with Bell's theorem, and how the usual objections voiced against the idea of ‘superdeterminism' can be overcome, at least in principle. This framework elegantly explains - and automatically cures - the problems of the wave function collapse and the measurement problem. Even the existence of an “arrow of time" can perhaps be explained in a more elegant way than usual. As well as reviewing the author’s earlier work in the field, the book also contains many new observations and calculations. It provides stimulating reading for all physicists working on the foundations of quantum theory.

The Cellular Automaton Interpretation of Quantum Mechanics

The Cellular Automaton Interpretation of Quantum Mechanics Book
Author : Gerard 't Hooft
Publisher : Springer
Release : 2016-09-13
ISBN : 9783319412849
Language : En, Es, Fr & De

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Book Description :

This book presents the deterministic view of quantum mechanics developed by Nobel Laureate Gerard 't Hooft. Dissatisfied with the uncomfortable gaps in the way conventional quantum mechanics meshes with the classical world, 't Hooft has revived the old hidden variable ideas, but now in a much more systematic way than usual. In this, quantum mechanics is viewed as a tool rather than a theory. The author gives examples of models that are classical in essence, but can be analysed by the use of quantum techniques, and argues that even the Standard Model, together with gravitational interactions, might be viewed as a quantum mechanical approach to analysing a system that could be classical at its core. He shows how this approach, even though it is based on hidden variables, can be plausibly reconciled with Bell's theorem, and how the usual objections voiced against the idea of ‘superdeterminism' can be overcome, at least in principle. This framework elegantly explains - and automatically cures - the problems of the wave function collapse and the measurement problem. Even the existence of an “arrow of time" can perhaps be explained in a more elegant way than usual. As well as reviewing the author’s earlier work in the field, the book also contains many new observations and calculations. It provides stimulating reading for all physicists working on the foundations of quantum theory.

A Practical Approach to Chiral Separations by Liquid Chromatography

A Practical Approach to Chiral Separations by Liquid Chromatography Book
Author : G. Subramanian
Publisher : Wiley-VCH
Release : 1994-10-17
ISBN : 0987650XXX
Language : En, Es, Fr & De

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Book Description :

Both analytical and preparative-scale enantioseparation techniques are covered in a down-to-earth practical way. The most important aspects of design, economics and safety are considered with emphasis on current European and North American legislation. In addition, the theory of chiral separation is covered in sufficient detail to guide the practising chromatographer interested in developing new techniques. A team of experts from academic and industrial laboratories throughout the world have compiled their findings and experience to make this book an exceptionally timely and unique contribution to the field.

Pharmacology

Pharmacology Book
Author : Miles Hacker,William S. Messer,Kenneth A. Bachmann
Publisher : Academic Press
Release : 2009-06-19
ISBN : 9780080919225
Language : En, Es, Fr & De

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Book Description :

Pharmacology meets the rapidly emerging needs of programs training pharmacologic scientists seeking careers in basic research and drug discovery rather than such applied fields as pharmacy and medicine. While the market is crowded with many clinical and therapeutic pharmacology textbooks, the field of pharmacology is booming with the prospects of discovering new drugs, and virtually no extant textbook meets this need at the student level. The market is so bereft of such approaches that many pharmaceutical companies will adopt Hacker et al. to help train new drug researchers. The boom in pharmacology is driven by the recent decryption of the human genome and enormous progress in controlling genes and synthesizing proteins, making new and even custom drug design possible. This book makes use of these discoveries in presenting its topics, moving logically from drug receptors to the target molecules drug researchers seek, covering such modern topics along the way as side effects, drug resistance, pharmacogenomics, and even nutriceuticals, one in a string of culminating chapters on the drug discovery process. The book is aimed at advanced undergraduates and beginning graduate students in medical, pharmacy, and graduate schools looking for a solid introduction to the basic science of pharmacology and envisioning careers in drug research. Uses individual drugs to explain molecular actions Full color art program explains molecular and chemical concepts graphically Logical structure reflecting the current state of pharmacology and translational research Covers such intricacies as drug resistance and cell death Consistent format across chapters and pedagogical strategies make this textbook a superior learning tool

An Overview of FDA Regulated Products

An Overview of FDA Regulated Products Book
Author : Eunjoo Pacifici,Susan Bain
Publisher : Academic Press
Release : 2018-06-13
ISBN : 0128111569
Language : En, Es, Fr & De

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Book Description :

Today’s challenge, especially for many newcomers to the regulated industry, is not necessarily to gather regulatory information, but to know how to interpret and apply it. The ability to discern what is important from what is not, and to interpret regulatory documents correctly, provides a valuable competitive advantage to any newcomer or established professional in this field. An Overview of FDA Regulated Products: From Drugs and Medical Devices to Food and Tobacco provides a valuable summary of the key information to unveil the meaning of critical, and often complex, regulatory concepts. Concise and easy to read with practical explanations, key points, summaries and case studies, this book highlights the regulatory processes involved in bringing an FDA regulated product from research and development to approval and market. Although the primary focus will be on the US system, this book also features global perspectives where appropriate. A valuable resource for students, professors and professionals, An Overview of FDA Regulated Products illustrates the most important elements and concepts so that the reader can focus on the critical issues and make the necessary connections to be successful. Provides an overview of key regulatory requirements using a practical approach that features detailed discussions of hypothetical and real-world case studies in order to highlight the concepts and applications of regulations Covers all FDA regulated products, including drugs, biologics, medical devices, cosmetics, foods, dietary supplements, cosmetics, veterinary products, tobacco and more in one single reference Illustrates complex topics in a clear, succinct and engaging manner by breaking down technical terms and offering straightforward and easy to understand explanations

Clinical Research Monitoring A European Approach

Clinical Research Monitoring  A European Approach Book
Author : Van Dooren A A
Publisher : World Scientific
Release : 2017-09-21
ISBN : 9813223197
Language : En, Es, Fr & De

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Book Description :

Clinical research monitoring is a vital aspect of Good Clinical Practice (GCP). Its principles are straightforward: they are aimed at protecting those subjects that participate in the trial, and their goal is to provide reliable data that will contribute to the safety and efficacy of the intervention under study, i.e. to support the health of future subjects. However, the practical implementation of these major goals is complicated. Various mishaps have happened in recent history, and an extensive set of international rules and regulations have emerged. This book gives a thorough survey of the ethical and legal aspects of clinical research and provides a detailed guideline for implementing these aspects into the practice of studying investigational medicinal products in humans, in the European context. It can be used as a study aid for starting monitors, a reference guide for more experienced monitors, and anyone else involved in clinical research. Contents: The PastMedicinal Products: The Development ProcessClinical Trials: Design AspectsThe Rules and the RegsThe Ethical Pillars of Clinical ResearchThe Players Part I: Ethics Committee and Data Monitoring CommitteeThe Players Part II: The Sponsor and the Clinical Research OrganisationThe Players Part III: The Investigator, the Sub-Investigator and the Clinical Research CoordinatorThe Players Part IV: The Pharmacy and the Clinical LaboratoryThe Players Part V: The Subject or PatientSafety Assessment and MonitoringThe VisitsThe Essential Documents Part I: Before Study StartThe Essential Documents Part II: During Trial ConductThe Essential Documents Part III: After Completion or Termination of the TrialData ManagementA Special Case: Medical DevicesComplianceThe Challenge of MonitoringThe Future of Clinical Trial Monitoring — Some Afterthoughts Readership: Clinical research monitors, clinical research associates, trial monitors, clinical research sponsors, contract research organizations (CROs), ethics committees, clinical investigators, and study nurses. Keywords: Clinical Research;Monitoring;CRA;GCP;Clinical Trials;Drug Development;Investigational Medicinal Products (IMPs)Review: Key Features: Current textbooks are US (FDA)-based, but this book covers the European situationProvides an up-to-date review of the theoretical and practical basis of clinical research monitoring and GCP, including the latest International Council for Harmonisation (ICH) GCP revisionsThe author has more than 10 years of experience in training and education of clinical research monitors