Ashfield Pharmacovigilance will host a live webinar that will focus on detection and management of drug safety signals. The live broadcast will take place on Friday, October 09, 2015 at 11:00am EDT (4:00pm BST/ UK GMT +1).
Signal detection is a necessary element of pharmacovigilance, which is mandated by EU regulatory requirements and strongly urged in the US by the FDA. Many tools and techniques can be employed to simplify this process and ensure your product is being proactively monitored.
Signal detection and trending is a powerful method used in the management of drug safety. This webinar will share the process of signal detection (detection, validation, analysis and prioritization, assessment and action) as detailed in the EMA Guideline on Good Pharmacovigilance Practices (GVP) Module IX – Signal Management and will also address the recommendations of the FDA. Additionally, we will focus on ways to tailor your signal surveillance approaches to best benefit your product’s drug safety profile, get the maximum value out of signals and drive patient safety.
Examples of signal detection through a multi-tiered approach will be provided, the roles of key players in the process will be introduced and the speaker will explore how the outcomes of signal detection and tending influence Benefit Risk assessments.
Ashfield Pharmacovigilance’s Partner for the Event
Xtalks, powered by Honeycomb Worldwide Inc., is a leading provider of educational webinars to the global Life Sciences community. Every year thousands of industry practitioners (from pharmaceutical & biotech companies, private & academic research institutions, healthcare centers, etc.) turn to Xtalks for access to quality content. Xtalks helps Life Science professionals stay current with industry developments, trends and regulations. Xtalks webinars also provide perspectives on key issues from top industry thought leaders and service providers.