Blood, Blood Components, and Plasma - Quality and Safety
Speakers
Dr. iur. Bita Bakhschai, Boltz, Scheller & Colleagues, Law Office, Germany
Dr Sally Baylis, Paul-Ehrlich-Institut, German Federal Institute for Vaccines and Biomedicines
Dr Zuzana Cermakova, Faculty Hospital Ostrava, Blood Center, Czech Republic
Dr Dragoslav Domanovic, European Centre for Disease Prevention and Control (ECDC), Sweden
Dr Barbara Glantschnig, Baxter AG, Austria
Dr Christine Günther, Apceth, Germany
Dr Stephan Kießig, Ruhrplasma, Germany
Dr Manuela Leitner, AGES, Austria
Prof Dr med Axel Seltsam, German Red Cross Blood Donation Centre, Springe
Prof Helmi Storch, Haemo Consult, Germany
Prof Erwin Strasser, University Hospital Erlangen, Germany
Objectives
During this conference, speakers from authorities, industry, sciences and donation services provide you with information about the current developments and revisions of the regulatory requirements, e.g. for virus safety or for process validation. You will also find out more about the strategies to accomplish the goal of a European standard. Furthermore, the developments in microbial safety – requirements and methods – will be introduced. You will benefit from experts presenting their practical experiences and knowledge in the field of quality and safety of blood, blood products and plasma.
Other information provided during this course includes Plasma Vigilance, quality requirements of plasma fractionators and therapeutic and preparative plasmapheresis issues.
Background
During the next years, blood donation services, plasma establishments and the plasma industry expect an increasing need of Source Plasma and following of donations in Europe and worldwide. Especially new applications of blood and plasma products – e.g. the use of IVIG for Alzheimers disease – can cause a rapid progression. Against this background, the number of donations must be increased to ensure the patient centred care as well as the supply of the industry. The amount of imported blood and plasma between the European countries as well as from USA will also increase. The necessary base for a comprehensive and sufficient maintenance in the EU countries is a consistent and standardised level of quality and safety of blood and plasma donations.
Based on the regulations of the European Union, e.g
Directive 2002/98/EC “Setting standards of quality and safety for the collection, testing, processing, storage and distribution of human blood and blood components and amending Directive 2001/83/EC”,
the “Plasma Master File”,
the European Pharamcopoeia or
the EDQM “Guide to the preparation, use and quality assurance of blood components”
integrative procedures for all countries are essential. Donor screening, microbial testing, donation practises and later on storage, distribution and look back systems should be on the same level in all member states.
Additionally, new guidelines and guideline drafts related to microbiological safety issues – like those related to HEV transmission or to classic GMP issues like process validation – have an impact on the field of blood and plasma products.
Target Group
This conference is designed for people from
Donation services
Authorities
Plasma Fractionation
Control Laboratories
who are involved in regulatory affairs, quality assurance, quality control and manufacturing of blood , blood products or plasma
Programme
Epidemiological challenges for blood and tissues in Europe
Emerging and re-merging infections
Donor derived infections
Surveillance system for infections transmitted through substances of human origin (SoHO)
Epidemiological data of some infectious diseases transmissible through SoHO
Dr Dragoslav Domanovic,, European Centre for Disease Prevention and Control (ECDC)
European legal framework
Regulations, Directives, Guidelines
Import of blood into the European Union
Blood donation, deferral and discrimination of MSM
Dr. iur. Bita Bakhschai, Boltz, Scheller & Colleagues
Guideline on process validation in the manufacture of biotechnology derived active substances and data to be provided in the regulatory submission (EMA/CHMP/BWP/187338/2014).
Introduction
Process validation
Points to consider in process validation
Dr Manuela Leitner, AGES
Blood Transfusion Service in CZ Republic- transition and adaption to EU standards
Organization and production of CZ blood transfusion service, changes during last 25 years
Cumberstones of transition from glass bottles / whole blood to standards common in EU countries
Implementation of quality
Harmonization with EU legislation
CZ self-sufficiency in blood components and plasma products: coexistence of hospital based BTS and independent plasma-collecting centers
CZ contribution to EU plasma pool
Dr Petr Turek, Thomayer Teaching Hospital, CZ
The German Qualified Person Assocation: Activities in the Field of Blood, Tissue and Cell-based Products
From blood and tissue to ATMP manufacturing: current challenges
Quality of starting material
Standardization of donation procedures
Specific consideration of autologous and allogeneic sourcing,
Dr Christine Günther, Apceth
Production and Usage of Blood and Blood Products in Germany
Regulatory Background for Data collection
Blood Donation
Preparation and Consumption of Erythrocyte- and, Thrombocyte Concentrates
Production of Plasma for Fractionation
Preparation and Consumption of Plasma Proteins,
Stephan Kiessig, Ruhrplasma
Regulatory Requirements on Stability Testing of Plasma Products
Guidance documents
Authorities Expectation
Classical Issues
Manuela Leitner, AGES
Plasma provider, fractionator, regulator – current challenges and proposed solutions
How do Changes at the plasma provider affect the fractionator?
Hurdles in the current Plasma Master File regulation: is there room for a more pragmatic approach?
Considerations on current donor deferral criteria and Look Back requirements for e.g. Tattoos, Piercings
Barbara Glantschnig, Baxter AG, Vienna
Plasma for fractionation in Europe- ways to get it
European Pharmakopoe
Different qualities
Concept of EU-self sufficiency
Close or far to the EU-goals
Steps to improve the situation
Prof Helmi Storch, Haemo Consult
Preparative apheresis and use of plasma products – regulative aspects and
common tasks
Donor selection and regulatory aspects
Quality aspects of apheresis plasma
Therapeutic use of fresh frozen plasma (FFP) and plasma products
Prof Erwin Strasser, Universitätsklinikum Erlangen
Donor vigilance in plasmapheresis
Physiology of blood donation and plasmapheresis
Regulatory requirements for donor vigilance
Established vigilance systems
Comparison of unexpected events in blood and plasma donations
Dr Stephan Kiessig, Ruhrplasma
Hepatitis E virus in blood and plasma donations – implications for fractionated products
Review of the EMA Workshop on Viral safety of plasma-derived medicinal products with respect to hepatitis E virus (HEV) including
Detection of HEV in blood/plasma donations
Epidemiology of HEV in donors
The clinical consequences of HEV infection
Virus reduction strategies for plasma products
Sally Baylis, PEI
Pathogen reduction treatment for non-fractionated blood products
Emerging pathogens,
Pathogen reduction technologies,
Clinical efficacy of pathogen-reduced blood components,
Outlook
Prof. Axel Seltsam, German Red Cross Blood Donation Centre, Springe
This course is part of the GMP Certification Programme "ECA Certified Regulatory Affairs Manager" Learn more
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