EMA workshop on the challenges in drug development, regulation and clinical practice for immunoglobulins

• Date:
  Wednesday, 05 March 2025 , 14:00 - 18:00 Amsterdam time (CET)
• Location:
  Online
  European 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.

Video recording

Documents

Meeting report - EMA workshop on the challenges in drug development, regulation and clinical practice for immunoglobulins

Reference Number: EMA/88993/2025

Agenda - EMA workshop on the challenges in drug development, regulation and clinical practice for immunoglobulins

Presentation - Authorised medicines and regulatory considerations by EMA (C. Gramiccioni)

Presentation - Clinical considerations on the use of IgG in primary immunodeficiencies (replacement therapy) (M. P. Cicalese)

Presentation - Clinical considerations on the use of IgG in secondary immunodeficiencies (P. H Asdahl)

Presentation - IVIG therapy in immune thrombocytopenia and FNAIT (J. J. Zwaginga, M. de Haas)

Presentation - Clinical considerations on the use of IgG in GBS and CIDP (Y. M. Falzone)

Presentation - Clinical considerations on the use of IgG in neuropathies (H. C. Lehmann)

Presentation - PPTA perspective on clinical development and clinical use of immunoglobulins (J. R. Knowles)

Presentation - EuropeBio perspectives on clinical development and clinical use of immunoglobulin medicines (V. Katkade)

Presentation - IPFA perspectives on the clinical development and clinical use of Ig (K. Pinachyan)

Presentation - HTA perspectives on challenges in drug development, regulation and clinical practice for immunoglobulins (A. Schiel)

Presentation - Monitoring of supply for immunoglobulins (K. Kruttwig)