EU Supply Shortage Management and the ESMP - Including legislative updates on the CMA and the new pharma package

- EU and national shortage monitoring: obligations, reporting criteria and deadlines for MAHs - Critical Medicines Act (CMA) and the new EU pharmaceutical legislation: impacts on shortage management - European Shortages Monitoring Platform (ESMP): data structure, monitoring scenarios and use in practice - Best practices for consistent and reliable data submission, including API-based automated reporting - Interactive case studyStay up to date on EU supply shortage management: reporting obligations, the Critical Medicines Act and practical ESMP guidance - in two focused half-day sessions.LernzieleThis online seminar provides a comprehensive overview of supply shortage management in the EU - from regulatory obligations to practical tools.- In module 1 you will gain a solid understanding of the EU shortage monitoring landscape, including key reporting obligations for MAHs at EU and national level, the role of EMA, NCAs and the SPOC network, and the implications of the Critical Medicines Act and the new EU pharma legislation for shortage management.- In module 2 you will explore the ESMP in depth - its data structure, the three monitoring scenarios and practical guidance on correct data submission, including API-based automated reporting.- Both modules will be recorded and made available to you after the event for flexible review.ZielgruppenThis seminar is aimed at regulatory affairs professionals, supply chain managers and other specialists in pharmaceutical companies who are involved in shortage reporting and supply security. It is also relevant for quality assurance, medical affairs and regulatory operations teams working with the ESMP or preparing for the requirements of the Critical Medicines Act.- Participants are expected to have a solid understanding of EU regulatory procedures.