EMA workshop on the challenges in drug development, regulation and clinical practice for immunoglobulins
EventHuman
- The original event time is:
- Wednesday, March 5, 2025 - 14:00 - 18:00 Amsterdam time (CET)
Date
- , -
Location
- OnlineEuropean Medicines Agency, Amsterdam, the Netherlands
Event summary
In line with the haematology work plan for 2025, this online workshop is 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 are:
• 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.