The safety of medical treatments is of paramount importance in the regulatory approval process, and conducting robust studies and surveillance to ensure treatments continue to be safe for patients once on the market is also vital. Evidera recently conducted a series of webinars focused on post-approval safety issues to share insights into regulatory changes, lessons learned, and best practices that can help you enhance your knowledge and planning of these types of studies. Whether your product may need a risk evaluation and mitigation strategy (REMS), or you need to plan for post-authorization studies in multiple nations or specifically for risk mitigation in Europe, or your product requires a pregnancy registry or lactation study, you can gain helpful insights from Evidera experts in these areas.
