Books

ISO 13485: A Complete Guide to Quality Management in the Medical Device Industry
Available
Written by an experienced industry professional, this practical book provides a complete guide to the ISO 13485 Standard certification for medical device manufacturing.

Healthcare Biotechnology: A Practical Guide
Available
Divided into six sections, the book begins with current systems and recent progress and controversy, major players and products, and a comparison with the pharmaceutical industry.

Usability Testing of Medical Devices
Available
This book offers a general understanding of usability testing and reviews key concepts, highlighting the challenges of validating that protects against dangerous errors that could lead to patient injury and death.

From Alzheimer's to Zebrafish: Eclectic Science and Regulatory Stories
Available

From quack medical devices that supposedly heal with mysterious powers, to the role luck and intuition have played in discovering some of our most effective and widely used drugs, Max Sherman’s From Alzheimer's to Zebrafish: Eclectic Science and Regulatory Stories is a fascinating and intriguing exploration of the quirky side of science.

Global Medical Device Regulations
Available
A compilation of chapters covering medical device regulation, adapted from the five books in RAPS’ Fundamentals of Regulatory Affairs series.

International Acronyms & Definitions
Available
A comprehensive list of acronyms, terms and definitions most commonly used by international regulatory affairs professionals.

Communication and Negotiation
Available
This book provides a basic description of communication and negotiation skills and their importance throughout all regulatory activities, both internal and external.

2012 CFR/ICH GCP Reference Guide for Medical Devices
Available
The CFR/ICH Reference Guide for Devices provides the critical information you need to know to stay current with the medical device and combination product industry’s codes and regulations.

2011 CFR/ICH GCP Reference Guide
Available
The CFR/ICH Reference Guide provides the critical information you need to know to stay current with the industry’s codes and regulations.

Fundamentals of US Regulatory Affairs, Seventh Edition
Available
This highly acclaimed publication is the perfect reference tool for any US regulatory affairs professional.

FDA: A History
Available
This DVD provides a comprehensive look at the history of the U.S. Food and Drug Administration. 

European Product Liability Law
Available
This book looks at product liability law in states both within and outside the EU, including Austria, England, France, Germany, Italy, Norway, Russia and Spain.

Fundamentals of Japanese Regulatory Affairs, First Edition
Available
This English edition is an indispensible resource for regulatory professionals working on products for the Japanese market.

Choosing the Right Regulatory Career
Available
This book looks at the wide range of opportunities available to those interested in the regulatory profession.

Life Sciences Law: Federal Regulation
Available
An updated and expanded comprehensive analysis of food and drug law topics and the federal agencies that regulate this burgeoning industry.

The Optimism Advantage
Available
Sharpen your skills and shape attitudes to achieve high levels of success personally and professionally

Drug Risk Management in Japan
Available
This is a comprehensive overview of current practices risk management practices for pharmaceutical products in Japan, including a comparison to systems in place in the US and EU.

Good Clinical Practice: A Question & Answer Reference Guide May 2011
Available
Provides answers to hundreds of FAQs in clinical research.

Introduction to the Due Diligence Process
Available
This book is the essential reference for regulatory professionals and pharmaceutical executives involved in the process of due diligence for product-based investments.

The Agile Approach to Adaptive Research: Optimizing Efficiency in Clinical Development
Available
This book outlines how adaptive research, using already-available tools and techniques, can enable the industry to streamline clinical trials and reach decision points faster and more efficiently.

Fundamentals of International Regulatory Affairs, First Edition
Available
This highly acclaimed publication is the perfect reference tool for any regulatory affairs professional working internationally.

US Regulatory Acronyms & Definitions Pocket Guide, Fourth Edition
Available
A pocket guide covering terms and definitions most commonly used by U.S. regulatory professionals.

Medical Device Development: Regulation and Law
Available
This practical reference provides the most comprehensive and updated analysis of US medical device and diagnostics development and approval requirements anywhere.

How the Mighty Fall
Available
This book offers leaders the well-founded hope that they can learn how to stave off decline and, if they find themselves falling, reverse their course.

Just Good Business: The Strategic Guide to Aligning Corporate Responsibility and Brand
Available
This book shows leaders and managers exactly how to connect their CSR efforts to their company’s overall corporate strategy, business objectives, and core competencies.

The FDA Advisory Committee Survival Manual
Available
This book that provides all the tools you need to strategize and prepare for an advisory committee hearing.

Pharmaceutical Risk Management
Available
This book will provide the practical guidance needed to understand, plan and implement successful risk management programs.

IND Submissions: A Primer
Available
The book provides a “hands-on” approach that will teach the necessary information needed to write the document and provides effective writing tips.