European Shortages Monitoring Platform (ESMP) training on CAP routine shortage reporting for MAHs

Kindly watch this recording of the European Shortages Monitoring Platform (ESMP) training session on routine shortage reporting for marketing authorisation holders (MAHs) of centrally authorised products (CAPs) that took place on 20 November 2024 and that aims to provide industry stakeholders with details regarding how to use the ESMP in preparation for the ESMP launch of the routine shortage reporting functionality on 28 November 2024. During this training, the ESMP team illustrates the importance and benefits of consistent reporting of shortages to the EMA, as well as the ESMP development progress, milestones and dependencies. The main part of the training focusses on how to establish the required user access roles and how to use the Platform to report shortages of CAPs to EMA through the routine shortage reporting functionality in the ESMP. Furthermore, questions raised through a dedicated Slido are answered at the end of the session and feed into the FAQ document on the ESMP webpage. This session is part of a series of events planned throughout 2024 and 2025 to promote awareness and knowledge about the platform and its use. Please note that reporting of CAP shortages to EMA is mandatory. For more information on this training, including the list of topics discussed, please visit the event page on EMA's website: https://www.ema.europa.eu/en/events/e... You may also wish to refer to the European Shortages Monitoring Platform Essentials and Industry Reporting Requirements webinar, held on 24 June 2024: https://www.ema.europa.eu/en/events/e... For more information and guidance on the ESMP, please visit the ESMP webpage: https://www.ema.europa.eu/en/human-re... If you have a question about the ESMP, you can send your question via AskEMA: Send a question to the European Medicines Agency: https://www.ema.europa.eu/en/about-us... 00:00:00 Opening of the training 00:05:45 Benefits of efficient shortage management in the EU/EEA​ 00:20:25 Overview of the ESMP 00:22:18 Reporting instances to ESMP 00:24:16 Release timeline 00:30:24 ESMP user access management 00:39:49 Demo: Requesting ESMP roles 00:46:39 Demo: Signing in to the ESMP 00:52:53 Routine shortage reporting functionalities 00:54:45 Preliminary requirements 00:56:04 How to navigate the platform 00:58:15 Scenario example: shortage reporting in ESMP 01:00:17 1. Product selection and template download 01:01:19 Demo: 1. How to select products and download the template 01:03:05 2. Data compilation and submission 01:17:09 Demo: 2. Template overview and submission 01:20:44 3. Perform updates 01:21:13 Demo: 3. How to update a shortage 01:23:31 4. Update a shortage as resolved 01:25:06 Demo: 4. How to resolve a shortage 01:28:30 Validation errors 01:29:48 Tips and Tricks 01:32:25 Best practices for accurate reporting 01:34:27 Useful Resources 01:36:34 Q&A session 01:58:47 Closing remarks