Medicines Safety and Pharmacovigilance

Medicines safety and pharmacovigilance: introduction, concepts, and applications is a reference offering pharmaceutical scientists a strategic roadmap to navigate the intricate world of medicine safety and vigilance, harnessing the expertise of professionals and ensuring the highest standards of patient care. This book helps assist key stakeholders with implementation and regulatory requirements, including reporting obligations, ethics, and communication about medicines safety. It also provides an overview of signal detection and risk management in healthcare settings. Importantly, this book covers latest information about recent technology advancements required for the modern-day needs of pharmacovigilance. The contents of the book include an introduction to pharmacovigilance, the regulatory framework for pharmacovigilance, healthcare professionals' experiences and expectations, safety surveillance methods, signal detection and management, risk management plans, case studies from high and low-middle-income countries, the role of pharmacists, pharmacovigilance in special populations, communicating medicines safety, ethical considerations, public-private partnerships, and future directions in pharmacovigilance. The role of digital health technology, more clearly big data and artificial intelligence in the field is also comprehensively covered in a dedicated chapter. Medicines safety and pharmacovigilance: introduction, concepts, and applications serves as an indispensable resource for pharma researchers, healthcare professionals, and policymakers, providing a thorough understanding of medicines safety and pharmacovigilance principles, methods, and applications. In an era marked by evolving technological landscapes and healthcare challenges, this book equips its readers to navigate the dynamic field of pharmacovigilance with confidence.

• Provides evidence-based practices in pharmacovigilance
• Offers a comprehensive overview of medicines safety issues, such as adverse drug reactions, drug interactions, and medication errors
• Describes the methods and tools used for safety monitoring, signal detection methods, data management, and observational studies in pharmacovigilance