Update webinar on Regulatory Procedure Management for Product Lifecycle Management on IRIS
EventHumanMedicines
Date
- Tuesday, 13 February 2024, 10:00 (CET) - 11:30 (CET)
Location
- Online
Event summary
EMA is currently working on the onboarding of Regulatory Procedure Management (RPM) for Product Lifecycle Management (PLM) for medicinal products on IRIS. The 1st roll-out occurred on 23 January 2024, covering Variations, Article 61.3 Notifications, and Marketing Authorisation Transfers procedures for a subset of both human and veterinary medicinal products.
The onboarding of regulatory procedures on IRIS will lead in the long term to process simplification and standardisation for MAHs, thus allowing the decommissioning of SIAMED.
This virtual event is designed to provide a comprehensive overview of RPM plans for the year 2024, offering a glimpse into the strategic direction, key objectives, and upcoming milestones. A focal point of the webinar is a live demonstration of the Industry Portal, allowing participants to explore its features and functionalities.
The event is primarily dedicated to all interested pharmaceutical industry companies (especially individuals with expertise in regulatory affairs). Do not miss this valuable opportunity to enhance your understanding and stay informed about the latest developments in this area.