Our Objectives and who we work with

Our objectives

As an international and outreaching objective, IPFA advocates for and encourages the development of a plasma strategy by the public sector in every country.

A plasma strategy is an integral part of a country’s public health effort. It is needed to enable robust, safe supply and equitable patient access to life-saving plasma-derived medicines, while ensuring sufficient resources in plasma to produce them.

By strengthening the contribution and ability of the public sector

  • to collect plasma within their communities
  • by finding suitable ways to organise its fractionation

countries and regions can increase the strategic independence of these vital medicines in a way which is aligned with wider public health policies and strategies.

Who we work with – our stakeholders
As an association, IPFA represents its members in discussions, negotiations and meetings with different stakeholders and partners. The main groups and stakeholders are described below: 

  • Fractionators
  • Plasma suppliers
  • Clinical testing institution

  • European Blood Alliance (EBA)
  • International Society of Blood transfusion (ISBT)
  • International Federation of Blood Donor Organisations (FIODS)
  • International Patients’ Organisation of Primary Immunodeficiencies (IPOPI)
  • World Federation of Hemophilia (WFH)
  • Platform of Plasma Protein Users (PLUS)
  • Arab Transfusion Medicine Forum (ATMF)
  • African Society of Blood Transfusion (AfSBT)
  • Alliance of Blood operators (ABO)
  • And others

  • US Food and Drug Administration (FDA)
  • European commission (EC)
  • European Directorate for the Quality of Medicines (EDQM) of Council of Europe
  • US Pharmacopeia (USP)
  • ECDC
  • European Medicines Agency (EMA)
  • MHRA
  • Paul-Ehrlich-Institut (PEI)
  • World Health Organisation (WHO)
  • And others

  • Plasma Products Therapeutic association PPTA
  • Companies in blood and plasma diagnostics
  • Companies in blood and plasma manufacturing technology
  • Market research (MRB)

  • Experts in blood-born pathogen safety
  • Experts in good manufacturing practices (GMP) for manufacturing
  • Experts in plasma manufacturing technology

 

IPFA Working Group on Regulatory and Clinical Affairs
The WGRCA brings together experts from the IPFA members and is responsible for maintaining awareness of relevant regulatory and clinical developments. This is achieved through surveillance, analysis and assessment of the impact of industry developments on IPFA member activities. The purpose of the Working Group is to ensure that members are able to establish and optimize appropriate development strategies. Also this Working Group covers regulatory guidance related to marketing authorisation of products, clinical trial authorisations, quality requirements on starting materials, blood components, and indications for Plasma Derived Medicinal Products. 

Where appropriate the Working Group will seek to influence and advise on regulatory developments through scientific publications and submission of evidence and opinion of its experts.  

IPFA prepares and publishes position papers on various topics related to our field. You can find the latest position documents in our news section link to news section 

For further information on the activities of the IPFA Working Group on Regulatory and Clinical Affairs please contact the chair: info@ipfa.nl