Global Clinical Trials Effective Implementation and Management 1st Edition by Richard Chin ISBN 978-0128103555 0128103558

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ISBN 10:  0128103558

ISBN 13:  978-0128103555

Author: Richard Chin 

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

Table of contents: 

Chapter 1. Background

• Introduction

• Growth of Global Clinical Trials

• Drivers of Globalization

• Issues of Globalization

• Control and Inspections of Foreign Sites

• Ethnic and Genetic Differences

• Usability of International Clinical Data in Regulatory Filings

• World Health Organization Prequalification Process

Chapter 2. Bioethical Considerations in Global Clinical Trials

• Introduction

• Ethical Standards and International Law

• Codes of Conduct

• Good Clinical Practice

Chapter 3. United States Regulations

• Overview of the Food and Drug Administration in the USA

• The FDA’s Legal Authority

• Requirements for Approval

• Use of Foreign Clinical Data by the FDA

Chapter 4. European Union Regulations

• Overview of the European Union

• Overview of the European Medicines Agency

• EMA Committees

• Regulations and Guidance Related to Product Authorization

• EMA Good Clinical Practices

• Requirements for Marketing Authorization Applications

• Medical Device Clinical Trial Requirements

Chapter 5. Japanese Regulations

• Introduction

• Documents Required for Application

• Review Process for New Drug Applications

• Required Surveys

• Contents Reviewed in the Drug Approval Application

• Differences Between J-GCP and ICH-GCP

• Notification of the Intent to Perform Clinical Trials

Chapter 6. Indian Regulatory Framework

• Introduction

• Regulatory Hierarchy

• Central Drugs Standard Control Organization

• Norms and Regulations for the Conduct of Global Trials

• Obtaining Permission for Conducting a Clinical Trial

• Health Ministry’s Screening Committee Clearance

• Clinical Trials Registration

• Special Considerations

• New Initiatives

• Conclusion

Chapter 7. Clinical Trials in India

• Introduction

• India: Background

• Demographics

• Disease Profile

• Healthcare System

• Indian Pharmaceutical Market

• India’s Changing Intellectual Property Rights Environment

• Regulatory Environment

• Ethics Committee Approval

• Good Clinical Practice in India

• FDA Audit and Inspection: Outcomes and Findings

• Language

• India’s Clinical Trial Sector

• Access to Patients

• Access to Investigators

• Access to Clinical Sites

• Working Effectively with Indian Clinical Trial Sites

• Pharmacovigilance

• Data Management Services

• Clinical Trial Supply Management in India

• Cost of Clinical Trial Services

• Clinical Trial Staff

• Conducting Trials in India

• Importance of India’s Clinical Trials Sector

Chapter 8. Chinese Regulatory Framework

• Overview of Drug Administration in China

• Drug Registration

Chapter 9. Clinical Trials in China

• Introduction

• Regulatory Climate

• Current Status and Statistics on Clinical Trials

• Overview of Investigators and Sites in China

• Contract Research Organizations

• Challenges and Opportunities

Chapter 10. Clinical Trials in Taiwan

• Introduction

• Regulatory Climate

• Current Status and Statistics on Clinical Trials

• Overview of Investigators and Sites in Taiwan

• Contract Research Organizations

• Challenges and Opportunities

Chapter 11. Clinical Trials in the Philippines

• Introduction

• Regulatory Climate

• Current Status and Statistics on Clinical Trials

• Overview of Investigators and Sites in the Philippines

• Challenges and Opportunities

Chapter 12. Clinical Trials in the Middle East and North Africa

• Introduction

• Clinical Trial Status

• Infrastructure and System of Healthcare

• Patient Profile

• Challenges and Opportunities

Chapter 13. Clinical Trials in South Africa

• Introduction

• Geography

• Healthcare System and Infrastructure

• Disease Profile

• History of Clinical Trials in South Africa

• Regulation of Clinical Trials

• Ethics Committees

• Good Clinical Practice

• Clinical Trial Status

• Participant Profile

• Inspections

• Pharmacovigilance

• Staffing of Clinical Trials

• Logistics

• Clinical Trial Industry Associations

• Challenges and Opportunities

Chapter 14. Clinical Trials in Latin America

• Introduction

• Regulatory Climate

• Current Status and Statistics on Clinical Trials

• Overview of Investigators and Sites in Latin America

• Contract Research Organizations

• Challenges and Opportunities

Chapter 15. Clinical Trials in Central and Eastern Europe

• Czech Republic

• Hungary

• Latvia

• Estonia

• Poland

• Romania

• Ukraine

• Russia

Chapter 16. Design of Clinical Trials for Emerging Countries

• Introduction

• Opportunities

• Challenges

• Recommendations

• Conclusion

Chapter 17. Study Management

• Introduction

• Planning and Project Management

• Selection, Qualification, and Management of Contract Research Organizations

• Central Laboratory Considerations

Chapter 18. Study Documents and Logistics

• Introduction

• Writing the Study Protocol

• Writing the Investigator’s Brochure

• Informed Consent and the Informed Consent Form

• Chemistry, Manufacturing, and Controls

• Drug Supply and Labeling

• Interactive Voice Response Technology

• Investigators’ Meeting

• Electrical Generators and Power Issues

• Translations

Chapter 19. Clinical Study Conduct and Monitoring

• Regulations and Harmonization

• Preclinical Study, and Chemistry, Manufacturing, and Control

• Phases of Clinical Development

• Clinical Study Conduct

• Clinical Study Team

• Clinical Study Protocol

• Case Report Forms

• Data and Safety Monitoring Board

• Investigational New Drug Application and the FDA

• Protecting the Research Subjects

• Study Start-Up

• Clinical Study Binder

• Subject/Patient Recruitment

• Site Monitoring Visits

• End of Study

• Audits and Inspections

Chapter 20. Data Collection, Data Management, and Electronic Data Capture

• Introduction

• The Electronic Data Capture Evaluation Team

• Electronic Data Capture Vendor Selection

• Narrowing the Field: Strategies for Second Round Selection

• Final Review

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