Menghis Bairu – författare

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

Global Clinical Trials for Alzheimer''s Disease is a handy one-stop reference for researchers and physicians planning and conducting global clinical trials in this area. This book addresses important considerations that may arise during the successful design and execution of these trials, including site selection, local regulatory issues, pharmacogenomics, ethical matters and much more. Given the saturation of traditional clinical trial markets and the worldwide progression of Alzheimer''s disease, there is a need to focus on clinical trials in emerging markets and developing countries. This book provides you with a practical approach to recognizing the opportunities and tackling the challenges that are present during the planning and execution of global clinical trials for Alzheimer''s disease.- Written by leading experts with hands-on experience in designing and running global Alzheimer''s disease and other neurodegenerative diseases clinical trials- A step-by-step guide that provides critical information on the design, conduct and standardization necessary to effectively execute clinical trials and accelerate drug development in this area- Includes practical examples, ethical considerations, lessons learned and other valuable tools to aid the planning and implementation of Alzheimer''s disease global clinical trials in emerging markets and developing countries

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

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