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
Compliance Services
Compliance Teleconferences and Webinar Providers
Corporate Espionage
Patent Baristas blog
Securing Innovation blog
Book: Spies Among Us
Book: Best Practices in Biotechnology Business Development
Cross-Functional Organizational Improvement
Book: The Fiefdom Syndrome
Book: Sun Tzu For Execution
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
Nanomedicine
New Product Development
Book: Design for Six Sigma
ISO 16982: Ergonomics of Human-System Interaction – Usability Methods
Book: The Medical Device R&D Handbook
Book: Winning at New Products: Accelerating the Process from Idea to Launch
by Robert Cooper
Open Innovation and Bookshelving
CoDev and Open Innovation Community blog
InnoCentive Open Innovation Marketplace
NIH/NCI Developmental Therapeutics Program
Microsoft Biology Initiative – open source library of bioinformatics
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
From Test Tube to Patient – a special report from FDA and FDA Consumer Magazine
Pew Internet & American Life Project Report
Professional Organizations
Ethics & Compliance Officer Association
Health Care Compliance Association
Institute of Internal Auditors
International Association of Risk and Compliance Professionals
International Society for Pharmaceutical Engineering
Pharmaceutical Compliance Forum
Product Development and Management Association
Regulatory Affairs Professionals Society
Regulatory Compliance Association
Society for Clinical Data Management
Society of Corporate Compliance and Ethics
The Organization for Professionals in Regulatory Affairs
Quality by Design
ICH Pharmaceutical Development Q8(R2)
Records Management
Book: Records and Information Management
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)
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
Training
Book: Training for Dummies
Voice of the Customer
Book: Acquiring, Processing, and Deploying: Voice of the Customer
by M. Larry Shillito
Book: Voice of the Customer: Capture and Analysis
Additional Websites and Blogs to Check Out
Data Quality Research Institute
Eye on FDA blog
Glossary of Common Clinical Trial Terms
GxP Perspectives blog
Institute of Validation Technology
OnPharma blog and forum
