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.:

• What should be taken into account when collating and updating the journal list for the reviews
• What should be taken into account when collating a search query
• If and when the information identified in the records, abstracts or full-text articles needs to be reported or referred to in the pharmacovigilance documents, or if it may be excluded from any further processing
• What conditions should be met to submit the information from a case report to EudraVigilance
• What day should be considered as day 0, and if this is a fixed day
• How to identify if the causality assessment was presented by the author
• If you need to follow-up on the article with the author
• If there might be any differences regarding the information obtained from the database record review, abstract review and full-text review
• What type of information may be considered as duplicate
• How to structure a document to keep the record of the search and review results