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Home » Your Career » Regulatory Career Advancement Guide » Senior/Executive Level Regulatory Professionals » Recommended Reading

Recommended Reading

Books

RAPS resources are essential to your career development. We offer a wide variety of industry specific publications that contain the information you need to succeed in your job and advance in your career. Visit the RAPS Store »

Biologics

Biologics Development: 3rd Edition
Biopharmaceuticals: Biochemistry & Biotechnology
Expediting Drug & Biologics Development

Canadian Regulations

2006 Fundamentals of CAN Regulatory Affairs
2004 Canadian Acronyms & Definitions

Clinical

HIPAA and Human Subjects Research
Protecting Study Volunteers in Research

Drugs

The Challenge of CMC Regulatory Compliance
Nanofabrication Towards Biomedical Applications
New Drug Approval Process: Accelerating Global Registration
The 'New' Part 11 and Drug Development
New Drug Development: Eighth Edition
Guide to Drug Development
Drug Truths: Disputing the Myths About Pharma R&D

Medical Devices

Medical Device Development

EU Regulations

EU Pharmaceutical & Medical Device Regulations
Fundamentals of EU Regulatory Affairs, 4th Edition
EU Acronyms and Definitions

Healthcare Law

Prosecuting and Defending Health Care Fraud Cases
A Day In Court: Critical Implications for Conducting Clinical Trials

Japanese Regulations

MHLW Ministerial Ordinances GQP and GMP

Marketing and Promotion

Pharmaceuticals: Where's the Brand Logic?
Promotion of Biomedical Products

Business and Leadership

Communicating in a Healthcare Crisis
The Expert's Guide to Healthcare Product Due Diligence
RAPS Scope of Practice & Compensation Study
True North: Discover Your Authentic Leadership
The CEO Within
Better
The Best American Science Writing 2006

Standard Operating Procedures

Cracking the Case of ISO 9001: 2000 Manufacturing

US Regulations

FDA Inspections & You (DVD)
US RA Acronyms & Definitions Guide
Fundamentals of US Regulatory Affairs, Fifth Edition
Title 21 CFR Pocket Guides (Various)

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Additional RAPS Materials

Commonly Used Acronyms in the Regulatory Profession
For a more extensive list of acronyms and definitions RAPS has developed Regulatory Acronyms and Definitions Guides written separately for the US, Canada and the European Union (EU). These quick and easy reference books cover hundreds of terms and definitions most commonly used by regulatory professionals.

Regulatory Information Resources
In an effort to provide resources to enhance the professional knowledge base, RAPS is providing access to Chapter 36 of Fundamentals of US Regulatory Affairs, Sixth Edition, "Regulatory Information Resources." This chapter was written by Diane R. Whitworth, a member of the RAPS Board of Editors with extensive experience in gathering regulatory intelligence.

White Paper
RAPS has released a new white paper, Regulatory Affairs Professional Development Framework: an Overview, which describes the knowledge, skills and abilities of regulatory professionals. This is the first report of its kind to be published. 

Articles in Regulatory Focus
Regulatory Focus magazine is the official monthly publication of the Regulatory Affairs Professionals Society, the foremost worldwide member organization creating and upholding standards of ethics, credentialing and education for the regulatory profession within the health product sector.

2010 Scope of Practice & Compensation Report for the Regulatory Profession
Every other year, RAPS conducts a Scope of Practice & Compensation Study that is designed to examine both the compensation and the range of duties and responsibilities–the "scope of practice"–of regulatory professionals working in the healthcare product arena. Data is collected from regulatory professionals around the world employed in industry, government, academia, research and clinical settings. Respondents are involved in a wide range of regulated healthcare products, including biotechnology, biologics, pharmaceuticals, medical devices, cosmetics and veterinary products.

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