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Home » Your Career » Regulatory Career Advancement Guide » New to Regulatory » New to the Profession » 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
Development of Investigational Therapeutic Biological Products
Preclinical Safety Evaluation of Biopharmaceuticals

Canadian Regulations

2006 Fundamentals of CAN Regulatory Affairs

Clinical

Clinical Trials & Human Research
Good Clinical Practice: A Q&A Reference Guide
Protecting Study Volunteers in Research

Drugs

The Challenge of CMC Regulatory Compliance
Nanofabrication Towards Biomedical Applications
Preparation and Maintenance of the IND Application in an eCTD Format
Key Regulatory Topics: CTD
Key Regulatory Topics: eCTD
New Drug Approval Process: Accelerating Global Registration
The 'New' Part 11 and Drug Development
The US Drug Approval Trends and Yearbook
A Framework for Pharmaceutical Risk Management
New Drug Development: Eighth Edition
Guide to Drug Development
The Pharmaceutical Regulatory Process, Second Edition
Drug Truths: Disputing the Myths About Pharma R&D 
Drugs From Discover to Approval
Quality Systems and Control for Pharmaceuticals

Medical Devices

CE Conformity Marking
Medical Device Development
Design Controls for the Med Dev Industry
Medical Product Regulatory Affairs
Reliable Design of Medical Devices

EU Regulations

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

Japanese Regulations

The Pharmaceutical Affairs Law
Drug Risk Management in Japan

Marketing and Promotion

Promotion of Biomedical Products
CE Conformity Marketing

Professional Development

Guidebook to Better Medical Writing
RAPS Scope of Practice & Compensation Study
True North: Discover Your Authentic Leadership
The CEO Within
Better: A Surgeon's Notes on Performance
The Best American Science Writing 2006

Standard Operating Procedures

Validation Standard Operating Procedures
Cracking the Case of ISO 9001: 2000 Manufacturing

US Regulations

Good Laboratory Practice Regulations
FDA Inspections & You (DVD)
US Regulatory Acronyms & Definitions Guide
Fundamentals of US Regulatory Affairs, Sixth Edition
How to Work With the FDA
FDA Regulatory Affairs
Title 21 CFR Pocket Guides (Various)
FDA: A History (DVD)

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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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