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
Year: 2025
Type: other
Abstract: 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...
Source: Hypotheses (OpenEdition)
DOI: 10.58079/13xya
Author: Vroby
Language: English
Field: Medicine
Domain: Health Sciences
Open Access status: green
OpenAlex ID: W6955243494
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