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Clinical Trial Events
DIA Europe

Talk Regulatory Operations track

S0804 - IDMP Data Harmonisation & Multi-Stakeholder Perspectives

Thu, Mar 20, 2025 · 10:30–11:40 AM CET Kairo 1-2 Room, Congress Center Basel

About this session

Standardised information on medicines according to international standards is crucial for ensuring their quality, safety and efficacy throughout Europe's healthcare system. It allows interoperability and data exchange among different stakeholders, such as industry, regulators, healthcare professionals and patients, and supports innovation and digital transformation in the pharmaceutical sector. However, creating and maintaining standardized data on medicines is not a simple task and requires collaboration and coordination among various actors at national, European and global levels.

This session will offer different perspectives from pharmaceutical industry, National Competent Authorities (NCAs), EMA and other global regulators on how standardised data on medicines is used, lessons learned and best practices. The speakers will share their experiences and challenges in implementing and applying international standards, such as ISO-IDMP, for managing data on medicines throughout the product lifecycle. Additionally, it will explore the current status and anticipated progress of IDMP implementation from a regulatory perspective.

Programme:
- Part 2 Panel Discussion — Remco Munnik, Isabel Chicharo, Sheila Elz, Georg Neuwirther, Sridevi Nagarajan
- Part 1 Setting the Scene — Remco Munnik, Isabel Chicharo, Sheila Elz, Georg Neuwirther, Sridevi Nagarajan
- 1. Introduction — Ana Lopez De La Rica Manjavacas

Speakers