The goal of this course is to bring you specifics of Global Medical Literature Monitoring in pharmacovigilance and one of topic dedicated course among 3 other MLM courses.

This course will give you proper background and knowledge regarding all necessary aspects, practical suggestions and tips which allows you actively involved in this area of Medical Literature Monitoring.

Basically we will discuss regulatory landscape and responsibilities of Marketing Authorization Holder and we will focus on the challenges connected with Global MLM. We will discuss when to start monitoring and when it could be terminated.

We will review specifics of databases and records structure, which should be taken into account during MLM.

We will take a look on database Thesauruses and their added value for the database searching and pharmacovigilance. Balancing of precision and recall will be discussed with focus on creating of query concepts and construction of database query.

I will point out basis of proper process documentation and I will present areas of the process which should be addressed in relevant process documents like SOPs or Working Procedures.

Also Quality assurance in Global MLM will be discussed.