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EMA workshop on the challenges in drug development, regulation and clinical practice for immunoglobulins held the 5 March 2025: publication of the presentation materials and the video recording of the event

In line with the haematology work plan for 2025, this online workshop was organised to have a multi-stakeholder’s perspective on the use of immunoglobulins as the scientific guideline on the clinical investigation of human normal immunoglobulin for subcutaneous and/or intramuscular administration (SCIg/IMIg) and Core SmPC are under public consultation until 31 May 2025.

These guidelines are aimed to define the data needed and clinical requirements for benefit-risk evaluation and obtaining marketing authorisation.

The aims of the workshop were:
•    To present the current regulatory requirements for the clinical development of immunoglobulins in support of a marketing authorisation application.
•    To present the clinicians’ / healthcare professionals’ perspective on the use of immunoglobulins and their view on established and new indications.
•    To present perspectives from industry and Health Technology Assessment bodies on the use of immunoglobulins.

Find the presentation materials and the video recording of the event on the EMA Website.


OpenEdition vous propose de citer ce billet de la manière suivante :
vroby (16 mai 2025). EMA workshop on the challenges in drug development, regulation and clinical practice for immunoglobulins held the 5 March 2025: publication of the presentation materials and the video recording of the event. ELSIBI. Consulté le 16 mars 2026 à l’adresse https://doi.org/10.58079/13xya


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