Clinical Research In Asia

Asia is increasingly taking on a leading role in the fields of Good Clinical Practice (GCP) and ethics, two areas that are central to clinical research practices worldwide. Clinical research in Asia examines the evolution of these key sectors in the Asian countries where the greatest developments are taking place, offering valuable perspectives on a wide range of issues affecting clinical research. Following an introduction that provides an overview of the topic and its strengths and weaknesses, each chapter of the book is devoted to clinical research in a specific country, focusing on issues including the history and evolution of clinical research, clinical trials and regulatory aspects. The chapters also offer a perspective on future trends in clinical research in each country. The book concludes with a discussion of the importance of political, economic, socio-cultural, technological, legal and environmental factors (PESTLE analysis). - Analysis from a leading and highly respected professional in the sector - An overview of country-specific regulatory environments - Discussion of challenges and solutions for clinical research

Medical device regulation in Asia has gained more importance than ever. Governments and regulatory bodies across the region have put in place new regulatory systems or refined the existing ones. A registered product requires a lot of technical documentation to prove its efficacy, safety, and quality. A smooth and successful registration process dem

This dissertation, "A multi-dimensional survey and critical analysis of clinical trial regulations in Hong Kong and a comparison of the status of clinical trial regulations in some Asian countries/Regions" by Hung-kin, Clive, Chan, 陳鴻健, was obtained from The University of Hong Kong (Pokfulam, Hong Kong) and is being sold pursuant to Creative Commons: Attribution 3.0 Hong Kong License. The content of this dissertation has not been altered in any way. We have altered the formatting in order to facilitate the ease of printing and reading of the dissertation. All rights not granted by the above license are retained by the author. DOI: 10.5353/th_b3197146 Subjects: Clinical trials - China - Hong Kong Drugs - China - Hong Kong - Testing Biotechnology - China - Hong Kong Clinical trials - Asia

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