Vaccine Adverse Event Reporting
Sources of Additional Information
Chapter 42Business Partners and Exchange of Safety Data
Why a Written Safety Exchange Agreement is Needed
Telling the Safety Department about a New Contract or Arrangement
The Generic, Boilerplate, or Template Agreement
Developing a Safety Agreement with the Safety Department
Pharmacovigilance Agreement Database
Health Authority Queries and Requests
Data and Mechanisms of Data Exchange
Signaling, Safety Reviews, and Risk Management
Chapter 43Data Privacy and Security
United States Health Insurance Portability and Accountability Act (HIPAA)
The European Union and the Privacy Regulation & Directive
Litigation, Lawyers, and Legalities
Organizations for Drug Safety Personnel
Chapter 45Real-World Issues: Case Studies
Fialuridine
Chapter 46Medical Marijuana and Pharmacovigilance
Overview and Pharmacology
US Federal Regulatory Situation