IRISS Forum IDMP Topic Group is organizing a RIM Vendor Showcase, demonstrating readiness with the EMA PMS API. As part of the European Medicines Agency’s SPOR system for the management of medicinal product information, the PMS system is now being opened for use through both a READ as well as a WRITE interface (API), under secured conditions. This means that Marketing Authorization Holders can connect directly via their Regulatory Information System. To demonstrate the readiness of the vendor community we have requested them to:
1) showcase their current capabilities in utilizing the PMS API (Read and Write) within their RIM solutions and
2) share their confirmed roadmaps with regards to future and/or expanded use of the PMS API within their RIM solutions.
We are aware that full utilization of this API will be most relevant when PMS submissions replace the current xEVMPD process (article 57) but it is our intention to inform the industry community of the status of the various vendors. The planned showcase will have 8 vendors presenting.
The session takes place for IRISS Forum members on 12 February, between 15:00 and 17:00 CET.
As IRISS is a non-profit organization, the showcase will be conducted under the same conditions for all vendors, excluding any commercials.