Pharmacovigilance

Safety comes first

Dokumeds has an extensive background in managing all aspects of drug safety and pharmacovigilance monitoring.  Our main services include: 

EudraVigilance

  • Registration within the EudraVigilance database (EVCTM) 
  • Responsible person for EudraVigilance 
  • EudraVigilance Medical Production Dictionary updates (EMPDU) 

Adverse Event (AE) and Adverse Drug Reaction (ADR) handling

  • Receipt, initial assessment and follow up with reporter
  • Assessment of seriousness, expectedness and causality
  • Narrative writing
  • Reporting to Sponsor and entering into Sponsor’s or Marketing Authorization Holder's (MAH's) safety database
  • MedDRA coding
  • Source records maintenance
  • Literature review for adverse drug reactions

Expedited submissions to Competent Authorities (CAs)

  • Using EudraVigilance Web trader (with or without safety database, able to produce E2B format)
  • Using Sponsor’s / MAH safety database and gateway

Other submissions

  • Periodic safety update (e.g. Annual Safety Reports (ASRs), Periodic Safety Update Reports (PSURs), submission to Ethics Committees / Principal Investigators / Competent Authorities 
  • Suspect Adverse Reaction Reports (CIOMS) creation
  • Expedited report submission to Ethics Committees / Principal Investigators

Standard Operation Procedures

  • Creation and development
  • Adaptation

Training PharmacoVigilance & Safety reporting

  • Training materials development and adaptation
  • Personal training

Medical writing*

  • Periodic reports (e.g. Annual Safety Reports (ASRs), Periodic Safety Updates Reports (PSURs)
  • Risk management plan
  • Detailed Description of PharmacoVigilance System

*Services with limited capacity