Clinical Strategy & Development, Pharmacovigilance

Expert Pharmacovigilance Solutions

1. Ensuring Drug Safety and Compliance
2. Proactive Adverse Event Reporting
3. Regulatory Compliance Assistance
4. Partnering for Patient Safety

Our Pharmacovigilance department specializes in the implementation and optimization of customized PV systems. Together with you, we develop individual solutions to set-up the optimal PV system tailored to your company size/product portfolio. Our pharmacovigilance team also helps you to manage and monitor all routine safety aspects of your medicinal product(s). Together with our trusted regulanet® partners in more than 70 countries worldwide we provide you with country-specific PV services. Our services include:

  • European Qualfified Person for Pharmacovigilance (EU/EEA-QPPV/-deputy function)
  • Local Safety Officers including the German Graduated Plan Officer/-deputy (‘Stufenplanbeauftragter‘, AMG §63a)
  • UK National contact person pharmacovigilance (UK NCP)
  • Organisation of regional Pharmacovigilance hubs, organization of Local PV responsible persons
  • Pharmacovigilance quality system set-up and management, including Standard Operation Procedure (SOP) writing
  • Pharmacovigilance System Masterfile (PSMF) development, maintenance and publishing
  • Individual Case Safety Report Management (whole workflow or individual workflow steps) and submission to competent authorities, including EudraVigilance, MHRA and Swissmedic
  • Signal Management
  • Local and global literature review
  • Screening of PV relevant webpages
  • GVP audits by certified auditors, vendor qualification
  • Medical Writing including Periodic safety update reports (PSUR) and Risk Management Plans (RMP)
  • Development (including communication plan) and support in distribution of Direct Healthcare Professional Communication (DHPC) and Educational Material
  • Safety data exchange agreements (SDEA)
  • Ad-hoc pharmacovigilance consulting
  • Pharmacovigilance trainings
  • Supports in Tissue- and Advanced Therapeutical Product (ATMP)-Vigilance set-ups

Clinical trial safety

  • Clinical trial safety officer/-deputy
  • Medical monitor for clinical trials
  • EudraVigilance responsible person for non-EU sponsors
  • SAE/SUSAR processing, reporting, and submission
  • Routine literature searches for ongoing risk-benefit assessments
  • DSURs

Question concerning Pharmacovigilance or Clinical Trial safety? Contact Claudia Köppel.

Medical device vigilance

Our vigilance team helps you to manage and monitor all medical device reporting aspects of your products to meet the European regulation´s requirements. Our services include:

  • EEA-qualified vigilance specialists
  • Vigilance quality system preparation and management
  • Post-marketing vigilance project management
  • Post-marketing case processing management including reporting of incidents and trends to competent authorities
  • Review of complaints to identify reportable and non-reportable incidents
  • Communication management with competent authorities, responsible manufacturer and incident originator

Post-market Surveillance

Our team helps you to manage and monitor the post-marketing phase of your medical device products so that it meets the European regulation´s requirements. We closely cooperate with our daughter company CE plus on vigilance support for post-market surveillance reports. Our services include:

  • Post-market signal detection to identify problematic events regarding your device
  • Local and global literature reviews
  • Regulatory and safety database searches
  • Periodic safety update report preparation
  • Update of clinical evaluation reports

Have a question concerning Medical device vigilance? Contact Claudia Köppel.