The European Medicines Agency (EMA) is gearing up for its upcoming Questions and Answers clinic focused on the Product Management Service (PMS) User Interface (PUI) and Application Programming Interface (API), scheduled for March 25, 2025. This online event, accessible globally, aims to provide comprehensive insights and address queries from industry stakeholders and National Competent Authorities (NCAs) regarding the latest updates in PMS tools.
Event Details and Accessibility
Set to take place from 11:00 to 12:00 Amsterdam time, the clinic will offer live broadcasts to accommodate international participants. Registrants will gain access to both human centrally authorised products (CAPs) and non-centrally authorised products (non-CAPs) data through the PMS interface. Notably, the PUI will transition to edit mode exclusively for industry users handling human non-CAPs starting January 31, 2025, while NCAs will retain read-only access.
Future Sessions and Registration
This session marks the first of a series, with subsequent Q&A clinics planned for April 29, May 19, and June 17, 2025. Interested parties must register by March 24, 2025, to participate. The EMA guarantees that video recordings will be available post-event, ensuring that those unable to attend live can still benefit from the discussions.
Participants can expect detailed explanations on the PMS API’s read-only capabilities, which will be accessible to both NCAs and industry users. The focus will extend to various authorization procedures, including mutual recognition (MRP), decentralised procedure (DCP), and national procedure (NAP), providing a broad understanding of data management within the PMS framework.
- Enhanced edit mode for industry users will streamline non-CAPs data management.
- Read-only access for NCAs ensures data integrity and security.
- Comprehensive coverage of MRP, DCP, and NAP procedures will be addressed.
- Future clinics indicate ongoing support and updates from EMA.
The EMA’s initiative to host multiple Q&A sessions underscores its commitment to transparent communication and support for stakeholders navigating the PMS tools. By facilitating direct interaction between the PMS team and users, the agency aims to foster a more efficient and user-friendly environment for managing medicinal products.
Providing detailed guidance and real-time support, these clinics will be instrumental for stakeholders aiming to optimize their use of the PMS interface and API. The availability of video recordings further enhances the event’s accessibility, ensuring that the wealth of information shared is preserved for future reference.
EMA’s strategic approach in conducting these Q&A sessions demonstrates a proactive stance in addressing potential challenges and equipping users with the necessary tools and knowledge. This initiative is likely to improve the overall efficiency of product management processes within the European pharmaceutical landscape.
The meticulous planning and comprehensive support provided by the EMA through these clinics will undoubtedly empower stakeholders to better navigate the complexities of PMS tools. By ensuring that both industry users and NCAs are well-informed and capable of effectively utilizing the PMS interface and API, the EMA is reinforcing its role as a pivotal facilitator in the advancement of medicinal product management across Europe.
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