The European Medicines Agency (EMA) is causing a lot of discussion with the introduction of new IT services. And companies are faced with the challenge of understanding the complex interrelationships of these new systems.
With the aim of harmonizing processes within the EU, the EMA has introduced a range of IT services. Terms such as SPOR, IRIS, PLM, ESMP and i-SPOC have emerged, and e-mails from the EMA call for registration.
SPOR (Substance Product Organization Referentials) aims to harmonize data standards, while PLM (Product Lifecycle Management Portal) is intended to facilitate the management of the lifecycle of products. IRIS serves as a communication tool between the EMA and other stakeholders and ESMP (European Shortages Monitoring Platform) monitors supply shortages. Companies must appoint an i-SPOC (Industry Single Point of Contact) as a central point of contact for the EMA.
What does this mean in concrete terms?
Who will be the administrator of these portals?
What obligations and responsibilities are associated with this?
Which information is mandatory and which can be provided optionally?
Diapharm understands the particularities of these systems and knows exactly what obligations and responsibilities fall on the various parties in the pharmaceutical industry.
Whether you need help with registration, defining the role of the PUI Industry Qualified User, or simply ensuring that your company meets all regulatory requirements – Diapharm can support you!
How exactly? Contact us!
