This beginner to intermediate level hands-on virtual live training course describes contemporary principles, practical approaches, and regulatory expectations for the Pharmacovigilance Quality Management System.

This practical virtual live training course will teach the EU RMP creation skills from both industry and regulatory perspective, including the project management, medical writing, design, and maintenance of the document. It also includes preview of the GVP V Rev 3 and RMP Template Rev 3.

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.