69.00€
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.
My name is Maciej Szewczyk and I’m CEO of MS Pharm company – pharmacovigilance provider fully dedicated to deliver Medical Literature Monitoring solutions to pharma industry, with strong focus on publications which are not easily reachable – means published locally and in native languages. I’m involved in this area of pharmacovigilance from 2009 on the different positions, from the project management, through business development including designing of dedicated MLM tools to CEO of company which currently manage over 130 MLM projects and cover over 1000 locally published medical and pharmaceutical journals.
I’m very lazy person in that way, that I’m always trying to automatize or at least maximally simplified all repeatable processes. That’s why we develop dedicated MLM tools which allow us to effectively manage projects we are responsible for.
I like to project and involve in development of software, which will make our life easier and more efficient. I love playing with numbers and statistics, that’s why I was involved in preparation of few analysis regarding literature in pharmacovigilance, e.g.
I’m also member of Polish Association of Pharmacovigilance and I was involved in creation of Literature Standard of Polish Association of Pharmacovigilance, which was published in Almanach of Polish Regulatory Authority – Office for Registration of Medicinal Products, Medical Devices and Biocidal Products.
Privately my biggest passion is badminton, skitouring and MTB.
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