Risk management in pharmacovigilance is vital for the safe use of medicines and safeguarding the health of patients. For industry professionals, risk management is a way to ensure that the benefits of the medicinal product outweigh the risks by a wide margin both at the individual and the target population level. Already a challenging task, the COVID-19 pandemic has only increased the complexity of pharmacovigilance risk management due to the rapid development of multiple COVID-19 vaccines and treatments.
In this on-demand webinar, we discuss the main challenges in pharmacovigilance risk management, including those related to additional risk minimisation measures needed for medicines and vaccines approved following accelerated procedures. We also propose possible ways to overcome these challenges and answer participant questions.
What will you learn?
- Main challenges in pharmacovigilance risk management
- Complexities of risks management in case of medicines and vaccines authorised through accelerated procedures
- Approaches to effective risk management
Who is the speaker?
Stefania De Santis – Director of Pharmacovigilance, seQure
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 the Pharmacovigilance Department ensuring timely and quality delivery of projects. During her career, she has been responsible for a 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.