After a brief reminder of the requirements for post market surveillance and post market surveillance plans from MDR, different methods used so far in pharmaceutical industry will be presented. This introduction will be followed by a case study which provides comprehensively the steps for building a typical tool for collecting data from a panel of healthcare professionals. The presentation will end with a discussion about lessons learned from pharma and caveats to avoid. Efforts will be made to make the presentation interactive, especially for the discussion part. Presentation will also highlight how the importance for post market surveillance increased in the MDR and how important it is for manufactuters to establish and run a system to actively collect information and feedback provided by users, patients and subjects related to the medical device. The link between the data collected and the life cycle including the clinical and PMCF will also be highlightened. A specific focus will give on how high quality PMS data can contribute to the regulatory compliance in the life cycle especially for high risk products e.g. revision of PMCF plans, PSUR drafting and submission, PMS reporting, Confirmation of device modification on the market.
Massoud Toussi is Senior Principal, Real World & Analytics Solutions, IQVIA, based in France and is the global lead for post authorization safety and effectiveness studies (PASS, PAES, REMS, DUS, Survey, Phase 4). He is a member of the working group which develops the Methodological guidelines of the European Network of centers of Pharmacoepidemiology and Pharmacovigilance (ENCePP). He is also the chair of the regulatory interactions and conditional coverage interest group of Health Technology Assessment International (HTAi).