Beyond Adverse Events

“Beyond Adverse Events: A Deep Dive into Drug Safety and Signal Detection” offers a comprehensive exploration of the intricate world of pharmacovigilance, providing readers with a detailed understanding of the principles, methodologies, and practices essential for ensuring the safety and efficacy of pharmaceutical products. From laying the foundational knowledge to exploring cutting-edge advancements, this book aims to equip healthcare professionals, researchers, regulators, and students with the tools and insights necessary to navigate the complex terrain of drug safety with confidence and clarity.

About The Book

Discover the essential guide to drug safety with Beyond Adverse Events: A Deep Dive into Drug Safety and Signal Detection. This comprehensive book offers healthcare professionals, researchers, regulators, and students a clear and detailed roadmap through the complex world of pharmacovigilance. Whether you’re new to the field or an experienced practitioner, this book delivers the foundational knowledge and advanced methodologies necessary to ensure the safety and efficacy of pharmaceutical products.

Structured into seven insightful chapters, Beyond Adverse Events explores the key principles and practices of drug safety, including signal detection, risk management, and real-world case studies. With a blend of practical examples and cutting-edge advancements, the book empowers readers to confidently navigate the intricate landscape of pharmacovigilance, addressing both current challenges and future innovations.

Whether you’re in the lab, the classroom, or on the regulatory frontlines, this essential resource equips you to contribute effectively to safeguarding patient health in today’s dynamic healthcare environment.

 

What’s inside

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CHAPTER 1

FOUNDATIONS OF DRUG SAFETY: Tracing the Historical Evolution of Drug Safety

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CHAPTER 2

UNDERSTANDING ADVERSE EVENTS: Distinction Between Adverse Events and Adverse Drug Reactions.

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CHAPTER 3

PHARMACOVIGILANCE IN PRACTICE: Exploring the Roles of Healthcare Professionals and Patients in Reporting Adverse Events.

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CHAPTER 4

BUILDING A STRONG FOUNDATION FOR MEDICATION SAFETY: The Key to Better Healthcare Outcomes

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CHAPTER 5

SIGNAL DETECTION METHODS: Quantitative Signal Detection.

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CHAPTER 6

EXPERT CONTRIBUTION BY JANAINA BROTHERS: VIGILANCE IN ACTION: PIONEERING SAFE PATHS IN PHARMACOVIGILANCE

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CHAPTER 7

FUTURE DIRECTIONS AND INNOVATIONS IN DRUG SAFETY

PREFACE BY JANAINA BROTHERS.

In the interconnected world of modern healthcare, it’s rare to find a voice that resonates with both clarity and depth on the topic of pharmacovigilance—a field where the pursuit of safety in medication usage is both a calling and a continuous challenge. It was through the professional network of LinkedIn that I first encountered Layo, an emerging luminary whose dedicated efforts have culminated in the creation of “Beyond Adverse Events: A Deep Dive into Drug Safety and Signal Detection.”

Layo’s work arrives at a pivotal moment in the field, representing a beacon of progress within the pharmacovigilance community, particularly in the United States where such comprehensive, domestically-sourced material has been sparse. Her book is a testament to the growing body of knowledge emerging from the U.S. and signals a burgeoning era in the domain of drug safety and monitoring.

Moreover, as a woman in this demanding sphere of expertise, seeing Layo lead such a significant endeavor is nothing short of inspiring. Her initiative to pen this authoritative work not only reflects her own commitment and prowess but also illuminates the path for women and safety professionals alike. In her stride, she opens wide the doors to innovation, understanding, and leadership in a field where diverse perspectives are crucial to advancement and success.

To the readers who are about to embark on the enlightening journey that Layo has so thoughtfully charted, I extend an invitation to engage fully with the wealth of knowledge within these pages. You stand at the threshold of a new frontier in pharmacovigilance. As you absorb the insights and lessons that this book offers, remember that you, too, are part of this transformative wave. Embrace this opportunity to contribute to a global movement that is reshaping the future of medication safety—one that relies on each of us to enact change and leave our indelible mark on the world.

In closing, I am reminded of the words of Walt Disney, a pioneer in his own right, who said,

We keep moving forward, opening new doors, and doing new things, because we’re curious and curiosity keeps leading us down new paths.

It is this spirit of curiosity and forward momentum that propels us to explore, learn, and evolve in our endless quest for knowledge and improvement.

Join us on this path; your insights and actions are invaluable in the collective mission to ensure the safety and well-being of patients everywhere. Together, let us continue moving forward, opening new doors in pharmacovigilance, and charting new paths to safeguard health across the globe.

Chapters

Pages

Whether you’re in the lab, the classroom, or on the regulatory frontlines, this essential resource equips you to contribute effectively to safeguarding patient health in today’s dynamic healthcare environment.

 

"Beyond Adverse Events" is a comprehensive journey through the complexities of drug safety and signal detection. The author adeptly navigates the reader through foundational principles to cutting-edge advancements, making it an indispensable resource for healthcare professionals, researchers, and regulators alike.

Erik Johansson

Public Health Advisor (Drug Safety)

European Centre for Disease Prevention and Control (ECDC)

This book is a masterful exposition on pharmacovigilance, equipping readers with the knowledge and tools necessary to navigate the intricacies of drug safety with confidence. The author's comprehensive approach, coupled with practical examples and case studies, makes this book an invaluable resource for healthcare professionals and researchers.

Elena Dumitrescu

Pharmaceutical Epidemiologist

European Monitoring Centre for Drugs and Drug Addiction (EMCDDA)

In "Beyond Adverse Events," the author offers a compelling exploration of drug safety and signal detection, providing practitioners with a thorough understanding of key concepts and methodologies. The book's structured approach, accompanied by real-world case studies, facilitates comprehension and application in clinical practice.

Oliver Mensah

Drug Safety Specialist

West African Health Organization (WAHO)

About the author.

Dr. Layo Emmanuel is a distinguished figure in the field of pharmacovigilance, serving as a Global Patient Safety Physician with a leading pharmaceutical company in the United States. With a profound dedication to ensuring drug safety and signal detection, Dr. Emmanuel is committed to advancing patient care and pharmaceutical standards worldwide.

In addition to her impactful role in patient safety, Dr. Emmanuel is the visionary founder and CEO of PharmAware Solutions, a pioneering career coaching and consulting company catering to medical doctors, PharmD holders, nurses, and life science graduates aspiring to transition into the Pharmacovigilance space. Through PharmAware Solutions, Dr. Emmanuel empowers professionals to excel in their careers while navigating the complexities of drug safety and regulatory compliance.

Outside of her professional endeavors, Dr. Emmanuel finds joy in her faith and family, cherishing moments spent with loved ones and nurturing her spiritual journey. A devoted follower of Jesus, she embodies compassion, integrity, and a steadfast commitment to serving others.

Dr. Layo Emmanuel

Expert Contributor.

Enjoy the Special Expert Contribution on VIGILANCE IN ACTION: PIONEERING SAFE PATHS IN PHARMACOVIGILANCE by Janaina Brothers (PharmD, MSRA)

Janaina Brothers 

A Deep Dive into Drug Safety and Signal Detection

Beyond Adverse Events

Whether you’re in the lab, the classroom, or on the regulatory frontlines, this essential resource equips you to contribute effectively to safeguarding patient health in today’s dynamic healthcare environment.