This track provides an overview of the global regulatory environment for clinical safety and pharmacovigilance for medical products (biopharmaceutical products, advanced therapies and medical devices). The focus is on pragmatic approaches for ensuring patient safety and ensuring that the patient voice is properly heard in the complex and evolving pharmacovigilance ecosystem. The forward-thinking sessions will address how to apply new technologies and methods for streamlining pharmacovigilance systems and processes. This will help enhance patient safety as products become progressively more complex, new data sources drive new analytical techniques, regulatory requirements become more demanding and medical product development becomes increasingly global.
Who is This Track Designed For?
Professionals involved in drug safety/pharmacovigilance, medical product safety risk assessment, pharmacoepidemiology (including real-world evidence generation), post-marketing studies (including Large Simple Trials and pragmatic safety studies), statistics, benefit-risk assessment and management, benefit-risk communication (including professional and consumer medical product safety labelling), regulatory affairs, clinical research (including clinical trial design), medical affairs and health outcomes.