Cumulative project statistics to date:

  • Authorship of more than 100 safety signal investigations, targeted literature reviews or safety data analyses
  • Authorship of more than 100 PSURs/PBRERs, DSURs and PADERs; various other PV writing activities
  • Conceptualisation and/or authorship of more than 70 risk management plans (mostly non-generic, full EU RMPs)
  • Safety representative in more than 10 safety due diligence activities and pharmacovigilance agreements
  • Expert auditor role in more than 10 pharmacovigilance audits
  • PV system consultancy for more then 10 companies, including authorship or revision of several PSMFs and development and authorship of more than 90 Policies, SOPs and other written procedures