Employing robust, fit-for-purpose pharmacovigilance computerised systems and procedures not only safeguards data integrity but also enables companies to leverage their data effectively. A deeper understanding of validation requirements and regulatory expectations can substantially shorten the time needed to implement and maintain these applications.

This virtual live training course covers essential principles that guide computerised systems in pharmacovigilance and provides guidance on how to implement and use these systems in a compliant manner and maintain these systems always audit ready.

This course is designed based on industry acceptable standards from US FDA, GAMP, EMA and MHRA guidelines, but will also cover other regulations as reasonably possible.

Participants benefit from the hands-on experience of trainers who have worked for many years in implementing and maintaining various computerised systems and are ready to not only explain the legislation but also provide personal experience and most commonly followed practices that are often considered as industry standards.