Module 12 Presentations

Key-take-ways

✓ There is a need for structured and standardised Medicinal Product data most importantly to improve patient safety

The Future

✓ ISO IDMP data standards have been developed to address these challenges. They are being implemented globally with EMA leading in implementation ➢ EMA SPOR plays a key role ➢ EMA started with optional PLM eAF submissions where part of data is the structured PMS (IDMP). This will move towards mandatory use and in future increase the PMS data scope ✓ xEVMPD submission are enforced today as a steppingstone towards more structured medicinal product data ➢ High quality xEVMPD data is of high importance due to use of this data across regulatory activities and EMA systems including PMS (IDMP) data ✓ Electronic Product Information ( ePI ) has potential to address many challenges for different stakeholders ➢ EMA is developing the PLM ePI portal that will link to IDMP (PMS) data ➢ ePI brings opportunities for industry to streamline information and utilise structured data

Data-driven paradigm, structured 2-way data exchange

The Organisation for Professionals in Regulatory Affairs