Tuesday, July 15, 2025

EMA Launches Monthly Q&A Sessions for Regulatory Data Management

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The European Medicines Agency (EMA) is set to enhance its support for stakeholders with the introduction of monthly Q&A clinics focused on Substance, Organisation, Referentials Management Services. Scheduled to commence on December 15, 2025, the online events aim to address queries and provide clarity on regulatory data management within the pharmaceutical sector.

Comprehensive Support for Industry Professionals

These interactive sessions are designed to assist pharmaceutical companies, healthcare professionals, and other related entities in navigating the complexities of EMA’s regulatory data management services. By offering a platform for real-time questions and expert answers, the EMA seeks to streamline processes and ensure compliance with regulatory standards.

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Extended Availability and Accessibility

In addition to the Substance, Organisation, Referentials Management Services, the EMA will also host dedicated Q&A clinics for the eXtended EudraVigilance Medicinal Product Dictionary (XEVMPD) until the end of 2025. Participants can access video recordings post-event, ensuring that valuable information remains accessible beyond the live sessions.

• Enhances understanding of EMA’s regulatory frameworks
• Provides direct interaction with EMA experts
• Facilitates timely resolution of industry queries
• Supports ongoing compliance and data management efforts

The EMA’s initiative reflects a commitment to fostering transparency and collaboration within the medicinal product landscape. By offering these structured Q&A clinics, the agency empowers stakeholders with the knowledge and resources necessary to thrive in a regulated environment.

By regularly engaging with industry professionals, the EMA not only addresses immediate concerns but also gathers feedback to improve its regulatory services continually. This proactive approach ensures that the agency remains responsive to the evolving needs of the pharmaceutical sector, ultimately contributing to the safe and effective availability of medicinal products across the European Union.

These Q&A clinics represent a strategic effort by the EMA to demystify regulatory processes and provide ongoing support to those navigating the complexities of medicinal product management. Stakeholders are encouraged to register early to take full advantage of these valuable learning opportunities.

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