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Products & Services Quality, Compliance and Regulatory Regulatory Affairs

Post-Marketing Surveillance Benchmarks: Monitoring for Adverse Drug Events

ID: 5045


Features:

7 Info Graphics

20 Data Graphics

100 Metrics

12 Best Practices


Pages/Slides: 38


Published: Pre-2014


Delivery Format: Online PDF Document


 

License Options:
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Single User: Authorizes use by the person who places the order or for whom the order was placed.

Sitewide: Authorizes use of the report for a geographic site. All people at site can view the report for a year and copies can be printed.

Corporate: Authorizes use for the entire company for a year and copies can be printed. No limitations for usage inside the company.




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  • STUDY OVERVIEW
  • BENCHMARK CLASS
  • STUDY SNAPSHOT
  • KEY FINDINGS
  • SPECIAL OFFER
Medical and bio-pharma sciences have witnessed enormous advancement in the past decades. As safety has grown into a critical issue for the U.S. Food and Drug Administration, it has become vital for the biopharmaceutical industry to maintain a dynamic post-marketing surveillance system. 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; Biotech; Health Care; Service


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


Study Snapshot

Representatives from 15 leading companies have shared their practices, views and information, to facilitate post-market surveillance system.

Key topics include:
  • 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

Sample 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.

If you purchase Best Practice Database document(s), you will have 30 days from the date of purchase to apply some or all of the cost of the document(s) toward the cost of a Full Access Individual, Pharma, Group or University Membership. Write us at DatabaseTeam@bestpracticesllc.com or call David Guinn at 919-767-9179 if you have any questions.