Biologics Working Party Plasma Master File Quality Operational Expert Group (PMF OEG)

The Biologics Working Party (BWP) Plasma Master File Quality Operational Expert Group (PMF OEG) is an operational expert group set up to support the BWP coordinators’ role in Plasma master file (PMF) certification as well as to provide support in matters related to the quality aspects of human blood and plasma.

Role

The PMF OEG supports the Biologics Working Party (BWP) core business providing scientific support on

• the peer review and assessment of PMF dossiers submitted to EMA for PMF certification
• safety and quality on topics related to the human plasma used for medicinal products and medical devices

The group’s main working area: Human blood and plasma quality and safety.

Mandate and rules of procedure

The PMF OEG is a group of experts with a BWP delegated role and responsibilities in the preparation of scientific recommendations to the BWP to support the EMA PMF certification. 

The group provides technical and scientific support on PMFs’ evaluation, related GLs and any topics in the field of human blood and plasma as per the BWP 3-year work plan 2025-2027:

• 3-year work plan for the Biologics Working Party (BWP) 2026-2028

Composition

CHMP nominates members to PMF OEG on the basis of their expertise and regulatory experience on the subjects covered within the PMF OEG scope. 

Members

The current members are listed below, in alphabetical order of surname. Their declarations of interests are available in the European expert list:

• European experts

Swissmedic may also nominate an observer to participate in the work of PMF OEG.

• Koenraad Brusselmans
• Karen Cristiano
• Angelo Ferreira da Silva
• Carola Govenius
• Tia Hirvonen
• Mats Jernberg
• Martina Joseph
• Sabrina Kneissl
• Eva Lindberg
• Veronika Pos
• Jens Reinhardt (Chair)
• Zsuzsanna Sasvari
• Irene Saugar
• Magdalena Szymaniak
• Maria Chamorro Somoza
• Marja van de Bovenkamp