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 ma...