Impact of medicines regulatory interventions in Europe: a systematic review focusing on unintended consequences, data used and methodology

Study type

• Study type:
  Non-interventional study

Non-interventional study

• Non-interventional study design:
  Systematic review and meta-analysis

Population studied

• Age groups:
  • Paediatric Population (< 18 years)

    • Neonate

      • Preterm newborn infants (0 – 27 days)
      • Term newborn infants (0 – 27 days)
    • Infants and toddlers (28 days – 23 months)
    • Children (2 to < 12 years)
    • Adolescents (12 to < 18 years)
  • Adult and elderly population (≥18 years)

    • Adults (18 to < 65 years)

      • Adults (18 to < 46 years)
      • Adults (46 to < 65 years)
    • Elderly (≥ 65 years)

      • Adults (65 to < 75 years)
      • Adults (75 to < 85 years)
      • Adults (85 years and over)
• Special population of interest:
  Hepatic impaired

  Immunocompromised

  Pregnant women

  Renal impaired
• Estimated number of subjects:
  0

Study design details

• Main study objective:
  The goal is to perform a comprehensive assessment of studies that evaluate the impact of pharmacovigilance regulatory interventions in the European Economic Area (EEA), focusing on identifying unintended consequences and highlighting the methodology and data used.
• Data analysis plan:
  We will perform descriptive analysis (totals and percentages) for data extracted from identified articles.