The goal of this course is to bring you basic understanding of Medical Literature Monitoring (MLM) concept in pharmacovigilance and is a basic course among other 3 MLM courses which are available on Aidify Platform. This course will give you proper background to be able actively involved in Medical Literature Monitoring and further explore that area of pharmacovigilance. Based on this course you should understand what role and position of Medical Literature Monitoring in pharmacovigilance is. We will discuss key regulations and guidelines relevant to that area and key concepts, principles and methods used. Also impact of different product categories on Medical Literature Monitoring requirements will be presented and impact of MA status on actions which should be taken in MLM will be presented.
You will learn roles and duties of different stakeholders involved in MLM process, particularities of EMA MLM service and possible models of MLM performing with their pros and cons.
Last but not least, we will focus on the areas which should be covered in formal documents relevant for Medical Literature Monitoring – contracts, SOPs or Working Instructions.