The overall aim of our association is to promote the interests of IPFA members and the patients they serve, and to inform stakeholders on our activities. Where appropriate, the IPFA Working Group on Regulatory and Clinical Affairs (WGRCA) collaborates with other industry associations and with patients’ associations to state and promote common values.
Working Group on Regulatory and Clinical Affairs
The WGRCA brings together experts from the IPFA membership 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 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 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.
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), EU Policy and Regulatory Authorities and other expert meetings. When necessary, IPFA requests ad hoc meetings with the authorities.
IPFA Regulatory and Clinical Affairs Working Group Members:
- Dr Françoise Rossi | IPFA | Working Group Chair, France
- Dr Stuart Chesneau | Australian red Cross Blood Centers (ARCBS), Australia
- Ms Jennifer Biemans | Canadian Blood Services (CBS), Canada
- Ms Stacy Conway | Blood Center of America, Inc. (BCA), USA
- Dr Trish Grace | Vitalant, USA
- Dr Jonathan Hughes | Vitalant, USA
- Dr Kostantinos Stamoulis | Hellenic National Blood Center (E.KE.A), Greece
- Mr Hiroyuki Ishikawa | Japan Blood Products Organization (JB), Japan
- Ms Christine Bertrand | LFB-Biomédicaments, France
- Mr Andre Germishuizen | National Bioproducts Institute (NBI), South Africa
- Mrs Khatija Suleman | National Bioproducts Institute (NBI), South Africa
- Dr Peter Flanagan | New Zealand Blood Service (NZBS), New Zealand
- Dr Leni von Bonsdorff | Sanquin Oy, Finland
- Ms Kati Mönkkönen | Sanquin Oy, Finland
- Ms Marja van Wijk | Sanquin Plasma Products B.V., The Netherlands
- Mr Stefanos Papamarkou | Sanquin Plasma Products B.V., The Netherlands
- Dr Titia Mulders | Sanquin Plasma Products B.V., The Netherlands
Contact with IPFA Working Group on Regulatory and Clinical Affairs
For further information on the activities of the IPFA Working Group on Regulatory and Clinical Affairs please contact the chair: firstname.lastname@example.org