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IPFA | EBA workshop on plasma collection by blood establishments

About

The European Blood Alliance and the International Plasma and Fractionation Association (IPFA), held an IPFA/EBA Workshop on Plasma Collection in Amsterdam, the Netherlands on 14-15 January 2020 at Corendon Village Hotel.

The IPFA/EBA Workshop on Plasma Collection focused on key considerations and strategies for increasing the supply of voluntary non-remunerated donation plasma for fractionation from blood establishments in Europe and other regions of the world and working towards the goal of strategic independence for the supply of Plasma Derived Medicinal Products (PDMPs).

Programme

The PDF programme with brief session descriptions is here.

Presentations

The presentations are linked in the programme below.

Day I: Tuesday 14 January 2020

9:00 SESSION 1 – Welcome and introductions
1. Why is a European plasma strategic independence important?

2. European Commission views
Stefaan van der Spiegel European Commission, DG Santé, Unit for Substances of Human Origin

3. EDQM activities in the field of blood components and PDMPs
Guy Rautmann, EDQM

4. Plasma Derived Medicinal Products (PDMP) and plasma supply into the future
Patrick Robert, The Marketing Research Bureau

10:45 SESSION 2: Responding to increased demand for PDMPs: examples
Chair: Cees Smit

The global demand for plasma for fractionation is expected to increase for the foreseeable future driven primarily by the increasing clinical use of immunoglobulin products. In this session colleagues from Belgium, Australia and Canada will describe how their strategies and policies have evolved to ensure a safe and secure national supply of plasma (both recovered and source) and PDMPs to meet patient needs – including monitoring and management of clinical use.

1. The Belgian experience
Philippe Vandekerckhove, the Belgian Red Cross Flanders Blood Services

2. The Australian experience
Sue Wilks, the Australian Red Cross Lifeblood

3. Navigating complexity: Ensuring security of supply of PDMPs in the Canadian context
J-P Bedard, Canadian Blood Services

Panel discussion

13:45 SESSION 3: Donor recruitment
Chair: Christian Erikstrup

Without blood and plasma donors, there would be no blood products to transfuse and no plasma donations for pharmaceutical drug production. However, often as little as 2%–3% of the population is registered as blood donor and donor numbers have been decreasing over the years. At the same time, the demand for specific blood products, especially plasma-derived ones, is increasing in times of demographic change, immigration and longevity. Hence, it is crucial that a country’s donor pool is sufficient, healthy and diverse enough to ensure access to every blood type and blood product that is needed. Targeted recruitment and retention of donors with specific characteristics are key in meeting the demands and improve donor management.
The aim of this session is to present evidence on donor motivation and barriers, show best practices from different countries in recruiting and retaining plasma donors and discuss ethical aspects around donor selection and blood safety.

1. Recruitment strategies and incentives for blood and plasma donors
Barbara Masser, University of Queensland, Australia

2. Ethics and safety in donor selection
Koen Kramer, Utrecht University, the Netherlands

3. Who gives (plasma)? Motivators and barriers
Eva-Maria Merz, Sanquin, the Netherlands

4. Plasma donor recruitment and retention / donor health: role of donor associations
Alice Simonetti, International Federation of Blood Donor Organizations (FIODS), Italy – Presentation is not available

Panel discussion

16:00 SESSION 4: The donation process
Chair: Anne-Marie van Walreven

The efficiency of the donation process to collect plasma, both source and recovered, is dependent on various factors. These factors are e.g. related to management elements, donor characteristics and technical aspects. During this session you will learn how to optimise the management of the collection process, personnel and the efficiency of the donation and processing of blood and plasma.

1. Management of blood and plasma collection
Frédéric Bigey, Etablissement Français du Sang (EFS), France

2. Improving apheresis efficiency
Hans Vrielink, Sanquin Blood Foundation, the Netherlands

3. Efficiency of collection practices – Case studies
Stephan Walsemann, Scinomed Deutschland GmbH, Germany, formerly of European Plasm Alliance and Bavarian Red Cross

4. Personnel requirements in European plasma centres – revisited
Matthias Gessner, European Plasma Alliance, Austria

DAY 2 – 15 January 2020

09.30 SESSION 5: Manufacturers session
Chair: Françoise Rossi

This session will provide opportunity for industries providing equipment, materials and support to Blood Centres and Establishments to present on technical and scientific developments in their companies in support of the goal of increased plasma supply.

Scinomed’s New Plasmapherisis Platform: “Does it deliver”
Stephan Walsemann

10.30 SESSION 6: Donor health
Chair: Rut Norda

Plasma donors often donate frequently. With the scale-up of plasma donation it is of paramount importance to assure that the procedure is safe. In this session we will present the knowledge on short and long term effects of plasmapheresis. We will also discuss what knowledge is missing and what studies we need to perform.

1. Impact on short term donor health
Johanna Castrén, Finnish Red Cross Blood Service, Finland

2. Impact on long term donor health
Jingcheng Zhao, Karolinska Institutet, Sweden

3. A plea for European donor vigilance
Christian Erikstrup, Aarhus University Hospital, Denmark – presentation is not available

Panel discussion

13.30 SESSION 7: Quality considerations for plasma for fractionation
Chair: Johanna Castrén

The collection and preparation of blood components and plasma for fractionation are highly regulated activities requiring comprehensive quality management systems to meet the standards prescribed by regulatory authorities and the plasma fractionation industry. This session will consider specific quality requirements for plasma intended for fractionation from the perspectives of both regulators and manufacturers together with a discussion of the wider benefits of plasma quality programmes for blood establishments.

1. Benefits of plasma quality programmes in blood establishments
Françoise Rossi, IPFA, the Netherlands

2. GMP/GP specific requirements for plasma for manufacturing
Sebastian Mérrien, Laboratoire Français du Fractionnement et des Biotechnologies (LFB), France

3. Regulatory considerations for plasma for fractionation
Jens Reinhardt, Paul-Ehrlich-Institut, Germany

Panel discussion

15:00 SESSION 8: Facilities and logistics – international experiences
Chair: Frédéric Bigey

This session will share the experiences from European, Australian and Canadian Blood Establishments of their current development and future plans for the efficient and cost effective large scale collection of recovered and source plasma from VNRDs. The aim of the session will be to identify key considerations for the development of infrastructure and logistical arrangements to optimize capacity, efficiency, cost effectiveness and donor experience.

1. Italy – Giancarlo Liumbruno, National Institute of Health, Italian National Blood Centre
2. Germany – Franz Weinauer, Blood Transfusion Service BSD/BRK
3. Australia – Sue Wilkes, Australian Red Cross Lifeblood, Australia
4. Canada – Marc Germain, Hema-Quebec, Canada

Panel discussion

Programme committee members are:

  • Eva-Maria Merz, Sanquin, EBA
  • Christian Erikstrup, Denmark, EBA
  • Frédéric Bigey, EFS, EBA
  • Edita Vilutytè, Estonia, EBA
  • Anne-Marie Van Walraven, Sanquin, EBA, Plasma Working Group
  • Paul Strengers, IPFA
  • Bob Perry, IPFA
  • Françoise Rossi, LFB, IPFA
  • Jean-Paul Bedard, Canadian Blood Services

With the support of Catherine Hartmann, EBA Executive Director and Mariska Mooijeking IPFA

  • 17 million donations
  • 470 million population
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