Preparation of the Periodic Safety Update Report (PSUR) is one of the new requirements introduced with the Medical Device Regulation (MDR). Although it shares the name with the well-known periodic safety report for medicinal products, its format and content are specifically tailored for the medical device.
Watch this on-demand webinar to get practical guidance to the latest PSUR requirements under the MDR alongside Post-Market Surveillance Report (PMSR) requirements.
What will you learn?
What are the transitional measures for medical device PSUR submission until Eudamed will be fully functional?
Which MDR rules on PSUR have an immediate effect?
Which medical device class of risk requires the PSUR?
Who are the speakers?
Stefania De Santis – Director of Pharmacovigilance
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.
Patrizia Secreti – Pharmacovigilance & Drug Safety Scientist
Patrizia holds a Bachelor’s and Master’s Degree in Pharmaceutical Chemistry and Technologies. After over 10 years of career in pharmacovigilance and drug safety departments of multinational companies, she has decided to undertake the freelance career as Pharmacovigilance & Drug Safety consultant.
Patrizia is also a study coordinator of an Italian clinical center specialised in intestinal bowel chronic disease (IBD) research and avid contributor to popular clinical research and healthcare blogs.
