The EMA is pleased to announce three public events taking place in July 2024 targeting Industry stakeholders and more specifically regulatory affairs, regulatory data management and regulatory systems sectors.

The broadcast/ registration links, agenda and presentations will be made available on the related event web pages. 

1.    Pack Size Submissions: from XEVMPD to PMS (event web page) 

This public webinar is taking place on 11 July 2024 (10:00 – 11:30 CEST). 

This is a webinar that will provide an overview of the entire process specifically related to how pack sizes information should be submitted to XEVMPD to support the European Shortages Monitoring Platform (ESMP) and how they will be incorporated into PMS, .  

The training will also provide practical recommendations to applicants on submitting this information effectively. 

Register to attend the event. 

2.    Product Management Service (PMS) Application Programming Interface (API) Training session (event web page) 

Following the read-only go-live of the PMS API – taking place on 1st week of July – for both Centrally Authorised Products (CAPs) and Nationally Authorised Products (NAPs), the EMA will host a public online training session on 8 July 2024 (14:00 – 15:30 CEST).  

During the session, the PMS team will provide a thorough explanation on access and navigation for the PMS API, including a comprehensive demo. 

Register to attend the event. 

3.    SPOR Status Update Webinar (event web page) 

The webinar providing a periodic update on Substance, Product, Organisation, Referentials (SPOR) Data Management services is currently scheduled on 10 July 2024 (10:00 – 12:30 CEST) and will be broadcast on the event web page. 

SPOR services aim to enhance the regulatory system by facilitating the reliable, robust and consistent exchange of medicinal product information and therefore enabling increased data quality and interoperability, efficiencies.  

During the event, the following information on the SPOR data management services (i.e. SMS, XEVMPD/Art.57, OMS, and RMS) will be provided: 

·         achievements in Q2 2024 

·         what is planned for Q3 2024 

·         what are the key highlights for SPOR users 

 

Note that this session will not include updates on the Product Management Service (PMS), as separate sessions for PMS are planned.