The focus of this Information Day will be on providing an update of ongoing Agency’s activities with regard to medicines’ risk management. This Risk Management Plan (RMP) Information Day will be an opportunity to provide marketing authorisation holders (MAHs) and marketing authorisation applicants (MAAs) practical advice on RMP drafting in view of the full implementation of the RMP revision 2 template after the transitional period has elapsed, as well as to interactively exchange experiences on the revision 2 RMP format between the regulators and industry.

The increasing number of biosimilars being authorised highlighted a need to better streamline the safety specification for biologicals so that only risks that are important for risk management and relevant for the benefit-risk of the product are included in the RMP. A dedicated session of the Information Day will also serve as a platform to discuss the streamlining of safety specification for biologicals with a special focus on biosimilars.

Updates on the work on the risk management aspects of the new GVP guidance on special populations such as children and elderly will be provided.

Other topics include risk communication as a key instrument for risk management coupled with the systematic publication of RMP summaries to ensure that the European system communicates risks effectively and in a timely and transparent manner.

The panel is happy to answer questions from the audience submitted to ema@diaglobal.org by 25 September 2018 latest.