Pharmacovigilance Update: Volume Ixa - What Are the Implications of the Changes?

Due to popular demand, this course is being brought to Brussels, Belgium. Volume IXa is an essential document used by the Regulatory Authorities as one of the pharmacovigilance guidelines for Pharmacovigilance Inspections. This is the third update of the Document (older versions were named Volume IX) and the purpose of this one-day course is to examine the new aspects and impacts of Volume IXa in readiness for Pharmacovigilance Inspections, compliance, safety reporting and the roles and responsibilities of the Company and European Qualified Person for Pharmacovigilance in terms of safety assessments in the European Union. The new Volume IXa provides greater clarity to old issues as well as detail a number of new aspects for the Safety Professsional to contend with. There are many new areas to be discussed in Volume IXa and delegate numbers to this course will be strictly limited so early booking is recommended.