In pharmacovigilance, case processing is the fundamental activity that provides data for the analysis of adverse effects that allows to detect new safety concerns and to periodically assess the benefit to risk ratio associated with the use of a pharmaceutical product. The precision and quality of safety data processing, also from the medical point of view, is crucial for ensuring correct analysis and undertaking corrective actions in timely manner, which in turn helps to safeguard the health of the patients and allows safe use of the drug.
During this webinar we will describe the best practices in case processing and common sources of bias and present case studies. The webinar will be followed by a Q&A session.
Date and time:
- Tuesday, June the 23rd, 16:00 – 17:00 CET
The key learning outcomes will be:
- Best practices in case processing
- Common sources of bias
- Understanding of the importance of continuous training in pharmacovigilance
Stefania De Santis – Director of Pharmacovigilance
Stefania has been working in pharmacovigilance since 1985. Prior to joining seQure she held a 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.