Cobert's Manual Of Drug Safety And Pharmacovigilance (Third Edition). William Gregory

Cobert's Manual Of Drug Safety And Pharmacovigilance (Third Edition) - William Gregory


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Dynamics in Play in Regard to Drug Safety and Companies

       Data Safety Management Boards and Ethics Committees/Institutional Review Boards

       Safety Assessment Committee

       Dynamics in Play in Regard to Drug Safety and Health Agencies

       Dynamics in Play in Regard to Drug Safety and Academic and Non-academic Healthcare Facilities

       Dynamics in Play in Regard to Drug Safety and Consumer Groups, Disease Groups, and the Internet (Blogs, Websites, Social Media, etc.)

       Dynamics in Play in Regard to Drug Safety and Lawyers/Litigation

       Codes of Conduct

       Comments and Summary

       Chapter 38The Safety Department’s Role in Clinical Research, CROs, Marketing and Sales, Labeling, Regulatory, Quality, Due Diligence, Legal Issues, Toxicology, Epidemiology, Medical Information and Manufacturing

       Clinical Research

       CROs

       Marketing and Sales

       The Labeling Department

       The Legal Department

       Regulatory Affairs Department

       The Quality and Compliance Department

       New Business Due Diligence

       Toxicology and Pharmacology

       Signaling and Epidemiology Groups

       The Medical Information/Medical Affairs Department

       Manufacturing (Product Quality Complaints)

       Chapter 39Drug Labeling

       Investigator Brochure

       Company Core Safety Information

       United States Safety Labeling for Marketed Products

       European Union Safety Labeling for Marketed Products

       Other Countries

       Comments about Labeling Content

       OTC Labeling in the United States

       Labeling Update Process

       Comments

       Frequently Asked Questions

       Chapter 40Universities and Academic Medical Centers

       The Bayh–Dole Act in the United States

       Clinical Research Units/Academic Study Units

       Translational Medicine

       Drug Safety Training in Academia

       North America

       Europe

       Academic Consultation

       Bad Behavior

       The Sunshine Act

       Chapter 41Vaccinovigilance

       Differences between Vaccinovigilance and Pharmacovigilance

       Causality versus Attribution

       Temporal Association

       Drugs are Metabolized; Vaccines are Processed

       Incidence and Prevalence of Adverse Event Symptoms

       Vaccine Efficacy

       United States Initiative: The Vaccine Adverse Events Reporting System

       GACVS and the European Commission

      


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