PharmaVOICE Blog Post

New Trends in Drug Safety and the Growing Role of Real-World Evidence

Posted By: Dan Limbach
December 10, 2018

Instant download of paper

A renewed focus on drug safety has emerged with the increased number of approved drugs, greater availability of information, and more direct involvement of patients in their treatments. Evidera’s latest paper covers the new trends regarding drug safety, and how Real-World Evidence is moving to the forefront.

Key Topics:

  • Shifts in Regulatory Thinking and the Increased Role of Real-World Evidence in Drug Safety
  • Real-World Data Definition According to the 21st Century Cures Act
  • The Era of Patient Centricity
  • New Conditions of Market Approval and Access
  • Rapidly Evolving Technologies and Methods
  • Patient Networks, Social Media, and Wearables: New Sources of Data
  • New Methodological and Analytical Approaches to Match New Data Sources
  • Natural Language Processing (NLP) and Machine Learning
  • Validated Systems and Methods
  • Sufficient Real-World Exposure Time Needed to Assess Safety Outcomes
  • Organizational Optimization: Shared REMS, Registries, or RWE Platforms

Read this white paper for more information on this topic

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About the Blog Poster: Dan Limbach

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