GLOBAL CLINICAL RESEARCH REGULATIONS: GUIDELINES FOR ETHICAL DRUG DEVELOPMENT AND GLOBAL COMPLIANCE

<p><b>GLOBAL CLINICAL RESEARCH REGULATIONS</b><br/><b>Guidelines for Ethical Drug Development and Global Compliance</b></p><p>&nbsp;<br/><b>Clinical research</b> is a cornerstone of modern healthcare driving the development of <b>innovative treatments</b> <b>vaccines</b> and<b> medical devices.</b> However navigating the complex regulatory landscape across different countries presents significant challenges for researchers sponsors and regulatory bodies alike.</p><p>Global Clinical Research Regulations: Guidelines for Ethical Drug Development and Global Compliance provides a comprehensive guide to the global regulatory frameworks that govern clinical trials. It explores the critical ethical considerations and compliance standards necessary for conducting trials across borders.</p><p>&nbsp;<br/>This book delves into essential topics such as:</p><p><b>Ethical Principles in Global Research: Informed consent participant protection and safeguarding vulnerable populations.</b><br/><b>Phase-Wise Drug Development: Detailed guidelines for Phase I-IV trials and post-marketing surveillance</b>.<br/><b>Multinational Regulatory Requirements: Insights into the FDA EMA and other global agencies' regulations ensuring adherence to Good Clinical Practice (GCP).</b></p>