Aggregate Report Development & Submission

FMD K&L’s team of safety professionals collaborates on each step in developing and submitting aggregate reports
Safety & Risk Management: Aggregate Report Development

Our team features physicians, scientists, and regulatory experts providing continuous assistance throughout the aggregate reporting cycle.

We support a wide variety of documentation involved in aggregate reporting. We can assist in preparation of any of the following documents or prepare them all as part of a comprehensive solution for aggregate reporting:
  • Periodic benefit/risk evaluation reports (PBRERs)
  • Periodic safety update reports (PSURs)
  • Addenda to clinical overview reports
  • Summary bridging reports
  • Periodic adverse drug experience reports (PADERs)
  • IND annual safety reports
  • Pharmacovigilance risk assessment committee (PRAC) responses/health authority responses
  • Developmental safety update reports (DSURs)
  • Benefit/risk profile reports
  • Literature search, analyses & ad hoc benefit/risk assessments
  • Data analysis & risk communications
  • Drafting of written responses to questions from regulatory agencies
  • Support for risk management plans (RMPs) & REMS