Challenge

As full-service pharmacovigilance provider, holder of PSMF and QPPV on behalf of a client, EUDRAC held a 2-day pharmacovigilance inspection by the German Competent Authority (BfArM).

Approach

Full hosting, preparation, collation and provision of documents, chairing and interview was performed by EUDRAC. EUDRAC’s approach was open, with detailed two-way discussions on the process and documentation of the pharmacovigilance system provided by EUDRAC. In addition, to the inspectors acquiring information on the EUDRAC system, via open discussion, the inspectors provided best practices from their perspective. This was welcomed and encouraged by the interviewees at EUDRAC and the rewards gained through the information provided by the inspectors were invaluable.

Conclusion

The inspection was very positive with zero critical and major findings. 

The information provided by the inspectors was mainly offering constructive suggestions for improvement of pharmacovigilance processes, which have been incorporated into EUDRAC’s Standard Operating Procedures (SOP).