Pharmacovigilance Conference

Major system changes, of which EV is a prime example, inevitably have a settling period during which both technical and procedural issues not seen in testing are likely to arise. The EMA are already aware of many concerns and challenges raised by industry and are addressing them on an urgent basis, plus some more specific challenges can be related to how an MAH has understood and implemented the requirements in their company. This session will review the current situation with respect to ICSR download and (very early) signalling experience, sharing knowledge gained and taking into account perspectives from across Industry (large, small, generics etc.) and Regulators. Additionally, the Panel Discussion will allow participants to directly interact with individuals working on both current issues and future development.