Webinar on Regulatory Procedure Management for Product Lifecycle Management 1st roll-out on IRIS

EMA is pleased to announce a public webinar for pharmaceutical industry companies (especially individuals with expertise in regulatory affairs) interested in learning more about the Regulatory Procedures for medicinal products onboarding on IRIS.

EMA is currently working on the onboarding of human and veterinary regulatory procedures on IRIS, with the aim to increase automation and efficiency, improve knowledge management and data security, and enhance transparency. The onboarding of regulatory procedures on IRIS will lead to process simplification and standardisation for MAHs, thus allowing the decommissioning of SIAMED.

The first procedures to be onboarded on IRIS are Variations, Article 61.3 notifications and Marketing Authorisation Transfers for a sub-set of Human and Veterinary medicinal products.

During the webinar, participants will have the chance to interact with the EMA product team, ask questions, and receive updates on the ongoing work related to regulatory procedures. The session will also include a demo of the Industry Portal in IRIS.

This is a valuable opportunity to enhance your understanding and stay informed about the latest developments in this area.

The registration form is available at Informative at Webinar on Regulatory Procedure Management for Product Lifecycle Management 1st roll-out on IRIS.

Registration is open until the start of the meeting.