Helpful Links

Compliance Organizations and Structures

HHS Office of Inspector General Corporate Integrity Agreements

HHS OIG’s Compliance Program Guidance for Pharmaceutical Manufacturers

Compliance Radar / Regulatory Intelligence

SmarterCompliance Newsletter

Compliance Services

Cerulean Associates

Compliance Teleconferences and Webinar Providers

Bioworld / Med-Tech



FOI Services

Corporate Espionage

Patent Baristas blog

Securing Innovation blog

Book:  Spies Among Us by Ira Winkler

Book:  Best Practices in Biotechnology Business Development ed. Yali Friedman

Cross-Functional Organizational Improvement

Book:  The Fiefdom Syndrome by Robert Herbold

Book:  Sun Tzu For Execution by Steven Michaelson

Foucault’s Panopticon

13 Things: Internalized Authority and the Prison of the Mind – Bentham and Foucault’s Panopticon

Foucault and Panopticism Revisited

Book:  Theorizing Surveillance: The Panopticon And Beyond ed. David Lyon


NIH Nanomedicine Roadmap

New Product Development

Bad Designs

Book:  Design for Six Sigma by Greg Brue and Robert Launsby

Innovation Tools

Institute for the Future

ISO 16982: Ergonomics of Human-System Interaction – Usability Methods

Book:  The Medical Device R&D Handbook by Theodore Kucklick

Book:  Winning at New Products: Accelerating the Process from Idea to Launch
by Robert Cooper

World Future Society

Open Innovation and Bookshelving

Collaborative Drug Discovery

CoDev and Open Innovation Community blog

InnoCentive Open Innovation Marketplace

NIH/NCI Developmental Therapeutics Program

Microsoft Biology Initiative – open source library of bioinformatics


Open Source Drug Discovery


Personalized Medicine & Comparative Effectiveness

FDA Genomics, Science & Research

HHS Personalized Healthcare Roadmap

HHS Federal Coordinating Council for Comparative Effectiveness Research

Medical Technology and Practice Patterns

Pre-Informed Patient

Bad Medical Devices Blog

Drug Alert

Drug Recall


From Test Tube to Patient – a special report from FDA and FDA Consumer Magazine


Pew Internet & American Life Project Report



Professional Organizations

ARMA International

Drug Information Association

Ethics & Compliance Officer Association

Food and Drug Law Institute

Health Care Compliance Association

Institute of Internal Auditors

International Association of Risk and Compliance Professionals

International Society for Pharmaceutical Engineering

Management Roundtable

Parenteral Drug Association

Pharmaceutical Compliance Forum

Pharmaceutical Quality Group

Product Development and Management Association

Regulatory Affairs Professionals Society

Regulatory Compliance Association

Society for Clinical Data Management

Society of Corporate Compliance and Ethics

Society of Quality Assurance

The Organization for Professionals in Regulatory Affairs

Quality by Design

FDA Critical Path Initiative

ICH Pharmaceutical Development Q8(R2)


Records Management

Book:  Records and Information Management by William Saffady

Book:  Winning Strategies for Successful Records Management Programs
by Mark Langemo

Regulatory Organizations

Centers for Medicare and Medicaid Services (US)

Committee for Medicinal Products for Human Use (EU)

European Medicines Agency (EU)

Food and Drug Administration (US)

Global Harmonization Task Force

Health Canada (Canada)

International Conference on Harmonization

Medicines and Healthcare Products Regulatory Agency (UK)

Ministry of Health, Labour and Welfare (Japan)

National Institute for Clinical Excellence (UK)

Pharmaceutical Inspection Co-operation Scheme

Therapeutics Goods Administration (Australia)

World Health Organization

Risk Management

FDA Hazard Analysis and Critical Control Point Principles and Application Guidelines

FDA Policy Manual on Assessing Need for a REMS for a New Drug or Biologic

ICH Q9 guideline Quality Risk Management

ISO 14971: Medical Devices – Application of Risk Management to Medical Devices

SOPs and Policies

Book:  Achieving 100% Compliance of Policies and Procedures
by Stephen Page

Book:  Seven Steps to Better Written Policies and Procedures
by Stephen Page

Book:  Writing to Learn by William Zinsser


Book:  Training for Dummies by Elaine Beich

Voice of the Customer

US Census Data

Book:  Acquiring, Processing, and Deploying: Voice of the Customer
by M. Larry Shillito

Book:  Voice of the Customer: Capture and Analysis by Kai Yang

Additional Websites and Blogs to Check Out

Biotech Blog

Compliance Alliance



Data Quality Research Institute

European Compliance Academy

Eye on FDA blog

Glossary of Common Clinical Trial Terms

GxP Perspectives blog

Institute of Validation Technology

OnPharma blog and forum

Pharmacy and Pharmaceutical Information on the Internet

Pharmaceutical Manufacturing Magazine