概要
This virtual live training course covers essential concepts of signal detection and signal management and provides guidance on how to apply these concepts at participants' function and their organisation, including the data mining techniques for large volume ADR data analysis.
The entire course is in line with the latest guidelines on EU Good Pharmacovigilance Practices (GVP): Module IX – Signal management (rev. 1), Commission Implementing Regulation (EU) No. 520/2012, CIOMS VIII and relevant EMA guidelines.
This training is primarily developed based on EU legislation, but it also covers regulatory expectations for signal management in the US, Switzerland, Canada, Australia, and few other countries.
Participants benefit from the hands-on experience of trainers who have worked for many years in signalling activities 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.
Participant Testimonials
The course content covered a wide range of topics, from signal detection algorithms to regulatory requirements and best practices. The instructors encouraged active participation and we learned a lot from other colleagues’ experiences. – Loredana Danila - Pharmacovigilance Specialist, Rompharm Company, Romania
With very good knowledge of the topics covered, adequacy in the answers to all questions, with very good presentation skills and the ability to arouse interest and hold attention!
