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