3 December 2025 | 13:30 – 17:30 CET | Online

Frequent changes to intended submission dates for initial and the unpredictability of post-marketing submissions place considerable strain on the EU regulatory network, affecting resource planning and coordination.

To address this growing challenge, DIA is organising a dedicated Information Day, facilitated by the European Medicines Agency (EMA). The aim is to foster a shared understanding of submission predictability, present key data trends and best practices for effective planning and strengthen collaboration between industry stakeholders and EU regulators.

Featured topics

• Overview on data and trends regarding submissions predictability
• Best practices approach for submission of initial marketing authorisation and post-marketing submission applications
• Impact analysis on resources when changing submission dates
• How to strengthen cooperation and communication amongst stakeholders

Who should attend

This event is designed for professionals involved in the preparation of initial centralised approved marketing authorisation submissions of medicinal products as well as post-marketing submission applications:

• Marketing Authorization Holders (MAH)
• Contract Research Organisations (CROs)
•  Sponsors of clinical trials
• Consultants

Register here.