Key Requirements Affecting Clinical Trials In Europe
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Key Requirements Affecting Clinical Trials In Europe 5th Edition
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Author : DAVID. HUTCHINSON
language : en
Publisher:
Release Date : 2017
Key Requirements Affecting Clinical Trials In Europe 5th Edition written by DAVID. HUTCHINSON and has been published by this book supported file pdf, txt, epub, kindle and other format this book has been release on 2017 with categories.
Key Requirements Affecting Clinical Trials In Europe
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Author : David Roger Hutchinson
language : en
Publisher:
Release Date : 2010
Key Requirements Affecting Clinical Trials In Europe written by David Roger Hutchinson and has been published by this book supported file pdf, txt, epub, kindle and other format this book has been release on 2010 with Clinical trials categories.
Key Requirements Affecting Clinical Trials In Europe
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Author : David R. Hutchinson
language : en
Publisher:
Release Date : 2007
Key Requirements Affecting Clinical Trials In Europe written by David R. Hutchinson and has been published by this book supported file pdf, txt, epub, kindle and other format this book has been release on 2007 with Clinical trials categories.
Global Clinical Trials Playbook
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Author : Menghis Bairu
language : en
Publisher: Academic Press
Release Date : 2012-06-12
Global Clinical Trials Playbook written by Menghis Bairu and has been published by Academic Press this book supported file pdf, txt, epub, kindle and other format this book has been release on 2012-06-12 with Medical categories.
Pharmaceuticals companies, biotech companies, and CROs, regardless of size, all face the same challenge of managing costs and operational execution associated with bringing a valuable drugs and devices to market. Because of timeline pressures and cost as well as the growing interest in "neglected diseases" and diseases affecting the emerging nations, clinical trials are increasingly conducted in emerging markets and developing countries where infrastructure, leadership, skilled personnel and a governance are at a premium. Working with academics, regulatory professionals, safety officers, experts from the pharma industry and CROs, the editors have put together this up-to-date, step-by-step guide book to building and enhancing global clinical trial capacity in emerging markets and developing countries. This book covers the design, conduct, and tools to build and/or enhance human capacity to execute such trials, appealing to individuals in health ministries, pharmaceutical companies, world health organizations, academia, industry, and non-governmental organizations (NGOs) who are managing global clinical trials. Gives medical professionals the business tools needed to effectively execute clinical trials throughout the world Provides real world international examples which illustrate the practical translation of principles Includes forms, templates, and additional references for standardization in a number of global scenarios
The Fundamentals Of Clinical Research
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Author : P. Michael Dubinsky
language : en
Publisher: John Wiley & Sons
Release Date : 2022-01-26
The Fundamentals Of Clinical Research written by P. Michael Dubinsky and has been published by John Wiley & Sons this book supported file pdf, txt, epub, kindle and other format this book has been release on 2022-01-26 with Medical categories.
This book focuses on the practical application of good clinical practice (GCP) fundamentals and provides insight into roles and responsibilities included in planning, executing, and analyzing clinical trials. The authors describe the design of quality into clinical trial planning and the application of regulatory, scientific, administrative, business, and ethical considerations. Describes the design of quality into the clinical trial planning Has end-of-chapter questions and answers to check learning and comprehension Includes charts that visually summarize the content and allow readers to cross-reference details in relevant chapters Offers a companion website containing supplemental training resources
Clinical Research Monitoring A European Approach
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Author : Van Dooren A A
language : en
Publisher: World Scientific
Release Date : 2017-09-21
Clinical Research Monitoring A European Approach written by Van Dooren A A and has been published by World Scientific this book supported file pdf, txt, epub, kindle and other format this book has been release on 2017-09-21 with Medical categories.
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
Patient Recruitment In Clinical Research
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Author : Danielle Jacobs
language : en
Publisher: Inst of Clinical Research
Release Date : 2005
Patient Recruitment In Clinical Research written by Danielle Jacobs and has been published by Inst of Clinical Research this book supported file pdf, txt, epub, kindle and other format this book has been release on 2005 with Clinical trials categories.
Provides ideas for how to improve patient recruitment for clinical trials.
Guide For Investigator Initiated Trials
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Author : Gerhard Fortwengel
language : en
Publisher: Karger Medical and Scientific Publishers
Release Date : 2011
Guide For Investigator Initiated Trials written by Gerhard Fortwengel and has been published by Karger Medical and Scientific Publishers this book supported file pdf, txt, epub, kindle and other format this book has been release on 2011 with Medical categories.
An essential manual for beginners and senior researchers alike For academic medical faculty unfamiliar with national and international regulations, the prospect of initiating and managing a clinical trial can be intimidating. The development of protocols and case report forms, compliance with regulatory requirements, the monitoring of clinical trials as well as the responsibilities of documentation are just some of the tasks the sponsor-investigator is faced with. This book covers the entire spectrum of a clinical trial, reviewing the different stages step by step: financial planning, crucial aspects of trial design, the authorization process and, finally, documentation. Moreover, it contains helpful tips, a practical glossary, instructions and a large number of resources related to the relevant regulations and forms conforming to the International Conference on Harmonization and Good Clinical Practice'. This makes the publication at hand an essential cookbook' for both academic faculty new to clinical trials as well as seasoned sponsors-investigators.
Clinical Trials In Belgium
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Author : Caroline Trouet
language : en
Publisher: Intersentia Uitgevers N V
Release Date : 2007
Clinical Trials In Belgium written by Caroline Trouet and has been published by Intersentia Uitgevers N V this book supported file pdf, txt, epub, kindle and other format this book has been release on 2007 with Law categories.
In line with its strong position in clinical research, Belgium was one of the first European Member States where the implementing regulation of the Clinical Trials Directive is fully operational. The specific conditions provided for in the legislation concerning experiments on the human person reinforce Belgium as a very attractive host for clinical trials, ensuring a lasting environment for innovative research. Pharma.be, the Belgian Pharmaceutical Industry Association, wants to contribute its part to research in Belgium by clarifying the practical implications of the new regulations. This new edition of the Operational Guidance does not only analyse the Belgian law from the perspective of the sponsor of a clinical trial, but also addresses the roles and tasks of all parties involved in clinical trials. In order to assist everyone involved in clinical trials, the Guidance provides for a short and comprehensive overview and insight into the process flows of the submission to and evaluation by the competent authority and the ethics committee of a clinical trials application. In addition, standard templates for the most important documents are added on a cd rom. This book is extremely useful, both for study sponsors and for all other actors in the field of medical research and development such as members of ethics committees, physicians, pharmacists, administrators, etc. The first edition of Clinical Trials in Belgium was very soon qualified as the standard textbook on the new EU legal framework and its transposition into Belgian law.
Global Clinical Trials
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Author : Richard Chin
language : en
Publisher: Academic Press
Release Date : 2011-05-06
Global Clinical Trials written by Richard Chin and has been published by Academic Press this book supported file pdf, txt, epub, kindle and other format this book has been release on 2011-05-06 with Science categories.
This book will explore the great opportunities and challenges which exist in conducting clinical trials in developing countries. By exploring the various regulations specific to the major players and providing insight into the logistical challenges including language barriers, this book provides a working tool for clinical researchers and administrators to navigate the intricacies of clinical trials in developing countries. Important topics such as ethical issues will be handled very carefully to highlight the significant differences of conducting this work in various jurisdictions. Overall, it will present a clear and comprehensive guide to the ins-and-outs of clinical trials in various countries to assist in design, development, and effectiveness of these trials. Contributors include high-profile, respected figures who have paved the way for clinical trials in developing countries Provides hands-on tools for regulatory and legal requirements and qualification, design, management, and reporting Case studies outline successes, failures, lessons learned and prospects for future collaboration Includes country-specific guidelines for the most utilized countries Foreword by David Feigel, former Head of CDRH at FDA