Confidence Beyond Compliance

On November 22nd 2017, the EMA launched the new EudraVigilance database (EVDAS) and gave Marketing Authorization Holders (MAHs) access to the system. MAHs are required to inform the EMA and national competent authorities of validated signals detected for their products. It is expected that the data from EVDAS is taken into consideration during the preparation of PSURs in order to complement and enhance the signal assessments and the conclusions for issues under close monitoring.

Our experts can assist with continuous monitoring of the safety data associated with your products. We provide assistance with the detection, validation, prioritization and assessment of signals working together with you to define and implement necessary actions.

  • Preparation and implementation of the Signal Monitoring Plan
  • Monitor the on-going signal tracker
  • Monitor the local ICSR database, Periodic Safety Update Reports and Risk Management Plans
  • Review of the scientific and medical literature, quality complaints, clinical and non-clinical trials
  • Periodic review of all regulatory information of your products (PRAC, referrals, CMDh, NCA’s websites)
  • Periodic monitoring of EudraVigilance Data Analysis System (EVDAS) and FDA Adverse Event Reporting System (FAERS)
  • Update of applicable SOPs