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Organisation  |  Working Groups

 

 

Working Group on Regulatory and Clinical Affairs (Chair Dr Françoise Rossi)
The Working Group on Regulatory and Clinical Affairs (WGRCA) brings together experts from 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 developments on IPFA member activities.

The purpose of this 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 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.

Representatives of the Working Group participate in stakeholder's meetings with Authorities, providing the opportunity to promote our principles and to influence regulatory developments. Also representatives of WGRCA contribute to and participate in scientific meetings, workshops as well as public meetings convened by regulatory authorities e.g. US Food and Drug Administration (FDA) and EU Policy and Regulatory Authorities, and other Expert meetings. When necessary, IPFA  requests ad hoc meetings with the Authorities.

The overall aim is to promote the interests of IPFA members and of the patients they serve, and to inform stakeholders on our activities.

Where appropriate the IPFA WGRCA collaborates with other Industry associations and with Patients' associations to state and promote common values. 

Working Group on BiologicalSafety (Chair Dr. Benoit Flan)
The Working Group on Biological Safety provides scientific analyses, state-of-the-art updates and scientific tools in the area of infectious diseases, virus safety, emerging blood borne pathogens, donor epidemiology and risk assessments.

The expertise available from its combined membership ensures that IPFA is able to use a science driven approach to contribute and react effectively to developments affecting the industry and in particular to those situations which may have impact on product and patient safety.

IPFA views are communicated by publications in peer reviewed scientific journals, and through participation in scientific and regulatory meetings..

Working Group on Public Affairs (Chair Dr Bob Perry)
The Working Group on Public Affairs provides guidance to member organisations for IPFA initiatives and public communication of IPFA and its members’ commitment to patient care and its underlying principles and objectives.