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GLOBAL CLINICAL RESEARCH REGULATIONS
Guidelines for Ethical Drug Development and Global Compliance
Clinical research is a cornerstone of modern healthcare, driving the development of innovative treatments, vaccines, and medical devices. However, navigating the complex regulatory landscape across different countries presents significant challenges for researchers, sponsors, and regulatory bodies alike.
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.
This book delves into essential topics such as:
Ethical Principles in Global Research: Informed consent, participant protection, and safeguarding vulnerable populations.
Phase-Wise Drug Development: Detailed guidelines for Phase I-IV trials and post-marketing surveillance.
Multinational Regulatory Requirements: Insights into the FDA, EMA, and other global agencies' regulations, ensuring adherence to Good Clinical Practice (GCP).
Dr. SK. Farahan Subahan, Dr. C. Madhavi Latha, Dr. Raghavendra Kumar Gunda
Dr. SK. Farahan Subahan Assistant Professor, Narasaraopeta Institute of Pharmaceutical Sciences, Narasaraopet
Dr. Subahan has over eight years of teaching experience and holds a Doctor of Pharmacy degree from Rajiv Gandhi University of Health Sciences, Bengaluru, Karnataka. Currently pursuing a Ph.D. at Bharat Institute of Higher Education and Research Centre, Selaiyur, Chennai, her research focuses on Immunology. She was honored with the Best Teacher award by the Association of Pharmacy Professionals in 2024. Known for her strong communication and teaching skills, Dr. Subahan effectively combines deep knowledge of pharmacy practices and principles with mentorship and leadership to create a dynamic and engaging learning environment.
Dr. C. Madhavi Latha Principal and Professor, Sree Venkateswara College of Pharmacy, Nellore, Andhra Pradesh
With over fifteen years of teaching experience, Dr. Latha has a diverse background in subjects including Human Anatomy and Physiology, Pharmacology, and Clinical Pharmacy. She holds significant roles in several prestigious organizations, serving as an evaluator and guide for Ph.D. scholars, and has been ratified by JNTUA, Ananthapur. Dr. Latha has presented at numerous national and international conferences and has published extensively, with more than 60 research papers, two books, eight book chapters, and 12 patents to her name. A recipient of multiple awards, including the Vidyaratna and Bharath Gaurav Puraskar, she maintains active involvement in the pharmacy community as a registered pharmacist and member of several professional bodies.
Dr. Raghavendra Kumar Gunda Associate Professor, Department of Pharmaceutics, Narasaraopeta Institute of Pharmaceutical Sciences (Autonomous), Narasaraopet
Dr. Gunda holds a Bachelor’s and Master’s degree in Pharmaceutics from Acharya Nagarjuna University, Guntur, and a Ph.D. from the School of Pharmaceutical Sciences, Vels Institute of Science, Technology and Advanced Studies, Pallavaram, Chennai. He has over thirteen years of experience in Pharmaceutical Product Development, specializing in novel drug delivery systems. Dr. Gunda has published more than 96 research and review papers and has been actively involved in the scientific community, presenting at various conferences and serving on editorial boards. His contributions have earned him numerous accolades, including the Best Researcher Award from the Association of Pharmacy Professionals.
