SAFE Task Force releases two position statements

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The Supply and Access for Everyone (SAFE) Task Force and IPOPI are happy to share with IPOPI’s members two position statements on 2 key topics of relevance to patients with PIDs worldwide:

These two papers aim at being used by NMO representatives in their advocacy work on access to immunoglobulin replacement therapies.

The SAFE Task Force, was launched by IPOPI in 2020 to monitor plasma collection and the availability of immunoglobulin replacement therapies for patients with PIDs worldwide, as well as provide guidance and support to patients with PIDs in their access to live-saving immunoglobulin therapies.
The taskforce is composed of experts from different parts of the world and IPOPI staff (in alphabetical order): Ms Roberta Anido de Pena, Ms Jose Drabwell, Dr Nahla Ewra, Prof Stephen Jolles, Dr Nizar Mahlaoui, Ms Martine Pergent, Mr Johan Prevot, Prof John Seymour, Prof Surjit Singh, Ms Leire Solis.

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Safety and Efficacy of Immunoglobulin: A Guide for Users, Assessors and Funders

This  IPOPI publication is available for download on our website. Within a national healthcare system, selection of immunoglobulin (IG) therapies for conditions such as Primary Immunodeficiencies (PIDs) is difficult. In well-resourced countries, regulatory agencies make key decisions regarding such therapies’ quality and safety; such regulatory agencies, including the U.S. Food and Drug Administration (FDA) and the European Medicines Evaluation Agency (EMEA), are dedicated to assessing products and to granting marketing licenses. However, even in countries lacking resources to form such regulatory agencies, selection of IG therapies for IDs, within a national healthcare system, can occur. For such selection to occur, national regulatory authorities (NRAs) need to understand and to use several well-established principles; this guide offers such principles to NRAs and others who are responsible for selection of IG therapies for IDs, within their respective national healthcare systems. While this guide was written with IG therapies in mind, many of its principles apply to all plasma-derived medicinal products.

Download PDF

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