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Best Practices for Post-Marketing Surveillance of Adverse Events within the U.S.

ID: POP-230


Features:

7 Info Graphics

20 Data Graphics

112 Metrics

9 Narratives


Pages: 37


Published: Pre-2014


Delivery Format: Shipped


 

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  • STUDY OVERVIEW
  • BENCHMARK CLASS
  • STUDY SNAPSHOT
  • KEY FINDINGS
  • VIEW TOC AND LIST OF EXHIBITS
Medical and scientific progress has been enormous in the past decades. However, this has also raised several safety issues leading to increased vigilance on bio-pharma companies by the U.S. Food and Drug Administration Authority. Under such circumstances, it is imperative for the bio-pharmaceutical industry to maintain a dynamic post-marketing surveillance system to ensure regulatory compliance.


This benchmarking study examines the best practices for post-marketing surveillance within the United States, as well as the processes for assessing reports of adverse events, follow-up activities and compliance training.

Executives and managers in Drug Safety can use this research to compare their group's staffing, makeup, AE evaluation process, reporting sources, follow-up activities and training with those of leading organizations.


Industries Profiled:
Pharmaceutical; Health Care; Biotech; Service


Companies Profiled:
Novartis; Boehringer Ingelheim; Novo Nordisk; Apotex; Stiefel; EMD Serono; Sepracor; Amgen; Biogen Idec; Vertex Pharmaceuticals; Eisai; Takeda Pharmaceuticals; Bracy Analytics Inc; ArthroWave


Study Snapshot

This benchmarking report examines the best practices for post-marketing surveillance within the United States, as well as the processes for assessing reports of adverse events, follow-up activities and compliance training. Executives and managers in Drug Safety can use this research to compare their group's staffing, makeup, AE evaluation process, reporting sources, follow-up activities and training with those of leading organizations. Representatives from 15 leading companies have shared their practices, views and information, to facilitate post-market surveillance system. Following are the key topics covered in this report:
  • Staffing and Workflow
  • Drug Safety Processes and Reporting Sources
  • Approach to AE Reports from Non-Traditional Sources
  • Approach to AE Reports on Another Manufacturer’s Product
  • Drug Safety Compliance Training
  • Marketing Program Involvement
  • Drug Safety Challenges

Key Findings

Staff Resources and Makeup: 80 percent of companies use physicians to review adverse event (AE) reports, more than 50 percent of benchmark partners also use pharmacists and nurses as reviewers.
  • Post-Marketing Surveillance Process: Some drug safety activities appear common in the industry, such as outsourcing low-level work and forwarding all AE reports of other manufacturers. Nearly 60 percent of the benchmark class outsource low-level work such as data entry within their drug safety groups.
  • Post-Marketing Adverse Events Reporting: Most of the companies said they report from a list of varied sources, 50 percent said they do not report from non-traditional sources such as blogs and interactive Web events.
Table of Contents

Study Overview 3
  • Key Findings & Insights 4
  • Benchmark Class 8
  • Staff Number (FTEs) and Makeup in Drug Safety Groups 10
  • Employee Groups Involved in AE Report Assessment 12
  • Process for Evaluating Adverse Event Reports 16
  • Most Common Reporting Sources of Adverse Event Reports 21
  • Main Methods for Follow-Up Activities 27
  • Adverse Event Report Training 31
  • Reporting Approach from Various Sources 35

List of Charts & Exhibits

Staffing of Drug Safety Department
  • Drug Safety Staffing by Function
  • Functions Responsible for Assessing Adverse Events Reports
  • Adverse Drug Event Reports Per Month
  • Sources of Adverse Drug Event Reports
  • Definition of "Affiliate" or "Company Representative" Clear at Company
  • Handling of Adverse Event Report for another Manufacturer
  • Follow-up Activities for Adverse Event Reports
  • Definition of Due Diligence
  • Obtaining Patient Consent to Contact Health Professional Regarding Adverse Event
  • Responsibility for Adverse Event Training
  • Methods of Training and Effectiveness Measures
  • Reporting Approaches for Adverse Events from Different Sources