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Pharmacovigilance Analytics

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Sources of data

Sources of data for PV analytics

Following is a non-exhaustive list of sources of data and information to be used in the framework of PV analytics.

Adverse event (AE) / adverse drug reaction (ADR) case reports

  • Company reports of AEs / ADRs generated during the entire life cycle of the medicinal product, which includes clinical development and post-market.
  • Health Agency databases: FAERS, EudraVigilance, Vigibase.

Studies

  • Nonclinical studies
  • Clinical trials, including research in unapproved populations or indications
  • Observational studies, real world data, registries
  • Systematic reviews and meta-analyses
  • Outcomes research studies
  • Comparative effectiveness research
  • Comparative safety research
  • Health economics analyses

Scientific literature

  • Published scientific literature or reports from abstracts, including information presented at scientific meetings
  • Unpublished manuscripts

Active surveillance systems

  • Sentinel systems or sentinel sites

Market access – market research

  • Product usage data and drug use information
  • Patient support programs

Healthcare – related data

  • Administrative and claims data from health insurers
  • Clinical data, including vital signs and laboratory test results
  • Electronic health records, electronic medical records
  • Hospital data
  • Medicare data

Internet

  • Marketing authorization holder-sponsored websites
  • Internet search engines
  • Patient forums
  • Social media channels

Other

  • Information arising from licensing partners, other sponsors, or academic institutions / research networks
  • Product quality investigations
  • Information from regulatory authorities
  • Information obtained from wearables
  • Ad-hoc reports generated by company field teams, and medical requests of information regarding potential benefits or risks

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