RESEARCH TRIANGLE PARK, N.C. — A new book provides a definitive drug safety resource for pharmaceutical researchers and students. The book brings together 136 experts from around the world who represent all aspects of pharmacovigilance.
The third edition of the textbook, titled Mann’s Pharmacovigilance, was co-edited by Elizabeth B. Andrews, Ph.D., vice president of Pharmacoepidemiology and Risk Management at RTI Health Solutions, a business unit of RTI International, and Nicholas Moore, M.D., Ph.D., professor of clinical pharmacology at the Université de Bordeaux.
Contributing authors included more than 30 government officials representing the Food and Drug Administration, European Medicines Agency, Agencia Española de Medicamentos y Productos Sanitarios, Italian Medicines Agency, and others regulatory bodies; industry experts from Amgen, Johnson and Johnson, Eli Lilly, Pfizer, and AstraZeneca among others; consultants; and dozens of academic researchers from around the world.
“Three editions and more than a decade later, I’m incredibly proud to continue playing a role in bringing this information to researchers, educators, practitioners, students, and the public,” Andrews said. “The level of professional collaboration on this book is truly outstanding and I am grateful to all those who contributed their expertise to demonstrate the importance of pharmacoepidemiology and pharmacovigilance in helping improve global public health.”
The book establishes the regulatory basis for pharmacovigilance and discusses regional pharmacovigilance systems in Europe, the Americas, Asia, New Zealand and Australia, and Africa. The book also explores signal detection and analysis; investigates pharmacovigilance in special population, product classes and specific therapeutic areas; and delves into current topics and training opportunities.
In addition to Andrews’ editorial role, three chapters in the book were contributed by RTI staff members.
- Kelly Hollis, global head of Surveys and Observational Studies and Alicia Gilsenan, Ph.D., senior director of epidemiology—both of RTI Health Solutions—authored a chapter titled Design and Implementation of Surveys to Assess Patient and Healthcare Provider Understanding of Risks and Safe Use Conditions.
- Suzanne West, Ph.D., fellow and senior scientist, and Wendy Visscher, Ph.D., privacy officer and senior Institutional Review Board advisor—both of RTI— contributed the chapter on Ethical Oversight, Consent, and Confidentiality.
- Bradford Walters, M.D., Ph.D., vice president and chief medical officer at RTI, authored a chapter on Neurological Adverse Events.
The book has been renamed in honor of Professor Ronald Mann, whose vision and leadership brought the first two editions, Pharmacovigilance, into being, and who dedicated his long career to improving the safety and safe use of medicines.
Mann’s Pharmacovigilance, published by Wiley-Blackwell, is available on leading commercial bookseller websites.
