69.00€
This course focuses on the setup of the Medical Literature Monitoring process in a daily practice. Referring to the particular chapters of the good pharmacovigilance practices (GVP) and the guidance on the Medical Literature Monitoring and the entry of the information into EudraVigilance by the EMA, the practical understanding of the requirements existing in the EU is discussed. From the course, you will learn e.g.:
My professional career includes holding the position of Medical Director in the local affiliates of pharma companies of global reach for several years. On top of other ones, my duties included oversight of local pharmacovigilance processes. As part of it, I was responsible for the setup and the oversight of the local medical literature activities. Being in the role of Drug Safety Officer or the deputy of the DSO for all those years, I had not only the chance to manage this area but also to translate the organizational frames into the daily pharmacovigilance activities in order to be certain the requirements as set out by the GVP are met. As the medical doctor with past academic experience, I am also able to understand the way the medical publications are edited, which adds to the ability to understand the unspoken information in the articles.
For the last 4 years, I have been being involved in supporting the local medical literature monitoring processes at MS Pharm s.r.o., a Czech-based company focused on providing the literature monitoring services. This tenure allows me to further expand my experience by confronting my understanding of the GVP requirements with the stakeholders in the pharmacovigilance area across the pharma industry. Looking at the literature monitoring from a number of different perspectives, it allows me to collate their experiences with these of mine in order to come up with the solutions that fit to the MLM best.
Don’t miss out on this opportunity to revolutionize your employee development process with AIDIFY’s freemium license. Fill out our form to get started today!
Reviews
There are no reviews yet.