Events
The Egyptian drug authority has held a free webinar regarding increasing the completeness score of the submitted adverse effect Reports (ICSR) for pharmacovigilance representatives of pharmaceutical companies
As the Completeness score of the submitted ICSRs has become an essential part of MAHs performance evaluation and will be closely monitored during inspections. This webinar has covered all the principles and the key points of submitting an ICSR with high completeness score and the common pitfalls of the MAH during their submission of adverse effect Reports (ICSRs)
The webinar also covers the completeness score from the PV inspection point of view to ensure the MAH’s compliance with the quality standards in the good practice of pharmacovigilance guidelines the queries of companies regarding the submission of ADRs were also answered.
This comes out of the EDA's vision to provide the necessary support to pharmaceutical companies, and in continuation of the EDA's role in supporting companies to improve their performance."
Tags
ICSRs
The Egyptian Drug Authority (EDA)