Objectives: To discuss the current state of play and recent developments in Europe with a major impact on plasma supply

Key discussion points:

• To discuss the EU SoHO Regulation and plasma supply continuity, while also addressing other relevant EU legislation and actions impacting the plasma supply chain.
• To discuss the 22nd Edition of the Blood Guide, including the approach taken and the rationale behind the revision of plasmapheresis standards. Additionally, to outline the next steps for the Blood Guide and standards related to plasma for fractionation.
• To get an overview of the current market landscape for plasma and immunoglobulins (Ig) in Europe and address other plasma proteins, including hyperimmune globulins.
• To explore the outcomes of the SUPPLY Project with a focus on the next steps and the need to increase and improve the supply of plasma in Europe.

Objectives: Building on a recommendation from the SUPPLY Project that additional high-quality studies are needed to determine an appropriate donation frequency for donor protection, this session will focus on recent developments and future plans in this area.

Key discussion points:

• To get an update on the recent data from an ongoing Norwegian study researching the effects of donation frequency on donor health in blood donors donating plasma by plasmapheresis.
• To get an update from the European Blood Alliance (EBA) and Plasma Protein Therapeutics Association (PPTA) on studies planned in this area.

Objectives: There is a need for robust donor registration and interoperability between donor centres and registries to strengthen donor protection across Europe. Effective donor registries can enable verification of donation frequency, support health monitoring and the management of donor adverse events and reactions, ensuring safe and sustainable donation practices. Donor registries may also facilitate the use of electronic health data for broader applications, including health research and public policy development.

Key discussion points:

• Perspectives on donor registration and interoperability from both collection and regulatory viewpoints.
• Experiences from countries with multiple independent collection centres.
• Challenges and needs in implementing national donor registries.
• The potential benefits and impact of donor registries.
• The future of donor registries, including digital health data integration.

Objectives: To exchange information and gather best practices in plasma collection, this discussion will explore perspectives on different collection models and address the needs and challenges in developing efficient, cost-effective processes for plasma, from collection through to release to the fractionator.

Key discussion points:

• Perspectives on different plasma collection models, exploring their benefits, challenges and specific needs.
• Strategies and approaches to optimise plasma collection processes.
• Key factors in developing cost-effective, sustainable plasma collection systems that ensure donor safety and process efficiency.

Objectives: This session will focus on the experience of fractionating domestic plasma in Europe from the fractionator’s perspective, identifying key challenges and needs and providing insights into the process.

Key discussion points:

• The experience of plasma fractionators in Europe with the fractionation of domestic plasma, discussing the associated challenges, needs and perspectives.
• Optimising the use of all plasma collected in Europe, including the potential creation of small pools from different member states and regions.
• Volume and IgG content – the value of plasma
• Addressing logistical challenges in the plasma supply chain, including transportation and storage, from the collector to the fractionator. Exploring strategies to increase sustainability in plasma fractionation, minimise waste and optimise plasma supply.
• Navigating the regulatory landscape for plasma-derived medicinal products (PDMPs), focusing on EU regulations, marketing authorisation and plasma master file (PMF) requirements and the ongoing revision of the EU pharmaceutical regulation.

Objectives: Amid the expanding indications for Ig use and known shortages of Ig products, this session will focus on the work of the European Medicines Agency (EMA) on the clinical use of Ig, and the mitigation and management of Ig shortages. There will be a specific focus on Anti-D Ig and consideration will also be given to other hyperimmune globulins.

Key discussion points:

• Outcomes of the EMA’s webinar on the clinical use of Igs, including the recent updates to their guidelines on subcutaneous Ig (SCIg) and intravenous Ig (IVIg).
• Anti-D Ig – addressing supply vulnerabilities and reviewing the outcomes of a recent EDQM/EBA survey.
• Hyperimmune globulins – challenges and perspectives for collection and supply.

Objectives: The SUPPLY Project identified two key elements for managing plasma collected for the public provision of PDMPs in member states:

• Political commitment – ensuring policy makers establish, resource and maintain a framework to support strategic independence in plasma and PDMP provision.
• Supply chain control – strengthening oversight of the plasma-to-PDMP conversion process.

Building on these recommendations, this session will consider plasma as a strategic resource from an economic perspective.

Key discussion points:

• Why plasma and PDMPs should be considered strategic resources.
• Why self-sufficiency in strategic PDMP matters, what the needs are and, in practical terms, how this may be achieved.
• Key economic and value considerations for plasma and PDMP in Europe

Objectives: The SUPPLY Project recommends for investment in the increase and improvement of plasma collection with the development of action plans in Member States.

Building on this recommendation, this session will provide an update on the latest developments from European member states and discuss the development of plasma action plans across Europe.

Key discussion points:

• Updates from the UK, Denmark, Italy and France to gain an understanding of their approach to the plasma value chain – from donation to PDMP supply – and how they set their targets, how they develop and implement their action plans (what are the key needs and what can be learned from this?) – and what they plan for the future?
• The key considerations and needs for member states in developing action plans for plasma supply continuity.