Risk management planning is an essential part of pro-active pharmacovigilance. In the EU, Risk Management Plans (RMPs) have to be submitted during application for a marketing authorisation for certain medicinal products. Risk Minimization Action Plans (Risk MAPs) may have to be written as part of a Risk Evaluation and Mitigation Strategy (REMS). In close cooperation with our clients, DADA can write and submit these product specific risk management documents to the competent authorities.