Ensuring Safety And Multivigilance Compliance Across The Product Lifecycle

The regulatory landscape for safety has changed dramatically over the last four years and shows no signs of slowing down any time soon. In this webcast, Oracle Health Sciences' Una Kessi, Product Management Director of Safety and Pharmacovigilance, and Robert Weber, Senior Product Strategy Manager, provide an update of the current situation worldwide, a preview of what the next few years will bring, and a solution using Oracle Safety Cloud to remain compliant through it all. Hot topics such as Brexit, combination products, E2B(R3), EVDAS/eRMR, medical device regulations, and IDMP are also included, and they break down safety regulations into several categories:

• Drugs, vaccines, medical devices, and combination products
• ICSR reporting, aggregate reporting, and signal management
• Clinical trials and post-marketing surveillance
• US, EU, Japan, China, and other countries/regions