Risk Management Plans (RMP) are required with every new marketing authorisation application in the European Union. Translating the results of the clinical and pre-clinical development into the safety profile of the product and reflecting the information in the Safety Specifications Module SVII of the RMP can be difficult without proper guidance and experience. This tutorial provides a detailed description of the risk identification principles in the newly revised “Guideline on Good Pharmacovigilance Practices: Module V – risk management systems” and practical exercises on identifying the risks of medicinal products, based on fictive development programme results. Participants will learn to distinguish between adverse drug reactions (ADRs), risks, and important identified/potential risks and missing information, and be able to identify the data required for an evidence-based risk identification in the RMP. The participants will apply the “RMP template for the industry” to write a RMP SVII Module by summarising and structuring the available data. The participants will also practice adapting and revising a RMP Module SVII based on results of the most common post-marketing pharmacovigilance activities. The tutorial will provide participants with the context for translating the safety profile of a medicinal product into post-marketing activities, both routine and additional.