”To err is human.. but to persist is diabolical”. Indeed, human error is a long standing problem which may have a critical impact on heavily regulated environments such as GMP, GCP and GVP. In pharmacovigilance, case management is the area in which human errors are the most frequent due to the large amount of data that has to be processed manually and due to stringent regulations. Other processes where human errors can occur include PSUR and DSUR preparation, literature screening, and many others.
In this on-demand webinar we explore the main causes of human errors, discuss the ways to minimise the risk in pharmacovigilance processes and present case studies. The webinar is followed by a Q&A session.
What will you learn?
- Most common causes of human errors
- Impact of human errors on pharmacovigilance processes
- How to minimise the risk of human errors
Who is the speaker?
Stefania De Santis – Director of Pharmacovigilance, seQure, the business unit of Arithmos
Stefania has been working in pharmacovigilance since 1985. Prior to joining seQure she held the position of Head of Corporate Drug Safety and qualified Deputy EU QPPV in a large pharmaceutical company where she managed Pharmacovigilance Department ensuring timely and quality delivery of projects. During her career she has been responsible for variety of pharmacovigilance operations in both pre-registration and post-marketing settings, case processing, PSUR and DSUR preparation, ICSR/SUSAR electronic transmission to the EMA, safety database validation, safety variations, signal detection, RMPs development, SDEA/Safety Management Plans and liaising with regulatory authorities.
Stefania is a qualified EU-QPPV and certified by EMA for the use of Eudravigilance and XEVMPD.