Saatja: <
[email protected]>
Saadetud: 16.03.2023 18:29
Adressaat: <
[email protected]>; SOHO <
[email protected]>
Koopia: <
[email protected]>
Teema: Call for interest: scientific expert panel for the development of
the ECDC technical guidelines on the prevention of donor-derived
transmission of communicable diseases through Substances of Human Origin
Dear Competent Authorities for blood, tissues and cells,
Please find below a message from ECDC SoHO team regarding a call for
interest for member of the scientific expert panel for the development of
the ECDC technical guidelines on the prevention of donor-derived
transmission of communicable diseases through Substances of Human Origin.
The deadline to respond is Monday 17 April 2023.
If you are interested and for further information, please contact
directly ECDC at .
Best regards,
The SoHO Team
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Dear Competent Authorities for SoHO,
The European Centre for Disease Prevention and Control (ECDC) is looking
to develop technical guidelines on the prevention of donor-derived
transmission of communicable diseases through Substances of Human Origin
(SoHO) in the European Union in the perspective of the proposed
Regulation on standards of quality and safety for SoHO.
These technical guidelines will be developed with the support of a
scientific expert panel that will support ECDC with technical and
scientific expertise on donor testing strategies, testing methods and
need for deferral where appropriate (including deferral period) which
will be considered for the drafting of the technical guidelines. The
present call for interest aims to establish an expert panel that will
provide advice for the following pathogens: Human Immunodeficiency Virus,
Hepatitis C Virus, Hepatitis B Virus, Treponema pallidum, and West Nile
Virus (WNV).
Therefore, should you meet the professional requirements detailed in the
in the attached Terms of reference document, we kindly ask you to
consider this call for interest. Alternatively, we would be grateful if
you could forward this call to relevant experts. The requirements are:
* University, or corresponding, degree in the field of medical or
biological sciences;
* At least 5 years of experience of working in blood, tissue, cells or
medically assisted reproduction establishments (this includes donor
testing laboratories) on donor selection, donor testing, quality
assurance or as responsible person;
or, alternatively, at least 5 years of experience on infectious diseases
covered by these terms of reference, and additional good understanding of
the field of SoHO;
* Experience in evidence-based decision-making.
The attached terms of reference also describe the tasks and expected
responsibilities of the expert panel.
To indicate interest to be part of the panel, experts shall send an email
stating interest to including a CV supporting the eligibility with
regards to the requirements. No later than 17 April 2023.
The scientific expert panel members will be selected by ECDC, primarily
based on professional capacity as outlined in the terms of reference,
aiming to ensure sufficient representation for the different types of
SoHO, reasonable gender representation and sufficient geographical
representativeness. The principles of non-discrimination, equal
treatment, and absence of conflict of interests apply.
As per ECDC procedures, the ECDC Director appoints experts for the ad hoc
scientific panel, following which a formal invitation will be sent.
Thank you in advance for your help in your support of this activity to
develop technical guidelines for the safety of SoHO under the new Blood,
Tissues and Cells Regulation.
Please do not hesitate to contact if you have any questions.
Kind regards,
ECDC SoHO team
European Centre for Disease Prevention and Control (ECDC)
Gustav III:s boulevard 40, 169 73 Solna, Sweden
Phone +46 (0)8 58 60 10 00
Follow ECDC on:
ECDC Terms of reference for a scientific expert panel
STI, Blood-borne viruses and TB (SBT)
Terms of reference for the scientific expert panel convened for the development of the ECDC
technical guidelines on the prevention of donor-derived transmission of communicable
diseases through Substances of Human Origin
15 March 2023, Stockholm
In July 2022, the European Commission adopted the proposal for a Regulation on standards of quality and
safety for substances of human origin (SoHO) intended for human application. The proposal’s scope includes
blood, tissues, cells, medically assisted reproduction and various other substances of human origin for human
application, with the exception of human organs for transplantation. The proposal will be discussed by the
Council and the European Parliament and when agreement is reached, and the Regulation is adopted and
published it will repeal the Blood Directive (2002/98/EC) and the Tissues and cells Directive (2004/23/EC). It
is estimated that the new Regulation will enter into force in 2024 with a date of application 2 years later.
Standards for the quality and safety of SoHO, including the prevention of communicable diseases transmission,
are currently defined in the directives. In the commission proposal, guidelines for the implementation of
standards for the prevention of communicable diseases transmission through SoHO are no longer listed. The
proposed Regulation establishes the European Centre for Disease Prevention and Control (ECDC) as an expert
body for developing and updating technical guidelines on safety and quality of SoHOs from a communicable
disease threat perspective. The proposed Regulation stipulates that SoHO entities in Member States shall
follow “the most recent technical guidelines […] published by ECDC concerning the prevention of
communicable disease transmission through SoHO donation [and] human application of SoHOs” (article 59(4)).
To prepare for the tasks listed in the proposed Regulation, ECDC will develop technical guidelines concerning
the prevention of donor-derived transmission of communicable diseases through SoHO in the European Union
and European Economic area (EU/EEA).
As part of the process for developing guidelines, expert panels will be established to address donor assessment
topics related to a predefined group of pathogens. The expert panel will provide ECDC with specific technical
and scientific expertise and deliver expert opinion to support ECDC in drafting the technical guidelines. The
task of the panel is to reach agreements on donor testing strategies, testing methods and need for deferral
where appropriate (including deferral period) related to the pathogens considered under these terms of
reference. These agreements will be considered by ECDC when drafting the guidelines.
The present terms of reference aims to establish an expert panel that will provide scientific advice on donor
testing and deferral strategies, as well as testing methods, for the following pathogens: Human
Immunodeficiency Virus (HIV), Hepatitis B Virus (HBV), Hepatitis C Virus (HCV), Treponema pallidum, and
West Nile Virus (WNV).
1/5
European Centre for Disease Prevention and Control (ECDC)
Gustav den III:s Boulevard 40, 169 73 Solna, Sweden www.ecdc.europa.eu
Phone: +46 (0)8 58 60 10 00 - Fax: +46 (0)8 58 60 10 01
ECDC is conducting a project covering the development of guidelines on
Development of technical
deferral and testing of donors for relevant pathogens, by donor and SoHO
guidelines on the prevention
type (excluding organs). Published guidelines will assist Member States in
of donor-derived
preventing donor-derived transmission of these pathogens when the
transmission of
proposed Blood, Tissues & Cells Regulation will come into application. The
communicable diseases
established process aims to ensure scientific quality, transparency, and
through SoHO
consistency of the development and publication of the guidelines.
Purpose and scope
The present terms of reference aim to establish a scientifc expert panel that
will provide scientific advice to support the development of guidelines
considering HIV, HCV, HBV, T. pallidum, and WNV.
The outputs of the scientific expert panel, in the form of technical reports,
will be taken into account for the development of technical guidelines
covering these pathogens, developed and published by ECDC.
The guideline development process includes:
o Collation of evidence by ECDC, assessment of the evidence by the
scientific expert panel and provision of expert advice on donor
testing and deferral strategies, including deferral periods, based on
risk (probability and impact) of pathogen transmission through
different SoHOs;
o Collation of evidence by ECDC, assessment of the evidence by the
scientific expert panel and provision of expert advice on test types
and/or testing methods for each pathogen;
o Development of technical guidelines by ECDC, based on the
assessments and advice of the scientific expert panel.
The scientific expert panel will be provided with data on the current SoHO
donor testing requirements and testing methods used in EU/EEA countries
for the considered pathogens. The scientific expert panel will also be
provided, for each pathogen, with a “pathogen data sheet” document
containing relevant epidemiological, microbiological, clinical and other
applicable data based on literature reviews, ECDC internal data and/or data
from relevant EU/EEA country authorities. The data presented in the
aforementioned documents will be gathered and processed primarily
internally by ECDC. Where applicable, provided data will be based on
documented targeted literature reviews, rather than systematic literature
reviews. Additional evidence, including systematic literature reviews, can be
requested by the scientific expert panel if deemed necessary.
The responsibilities of ECDC are to:
Responsibilities
o Provide data on current SoHO donor testing requirements and testing
methods used in EU/EEA countries for the pathogens under
discussion;
o Provide a “pathogen data sheet” for the pathogens under discussion;
o Provide additional evidence upon request of the scientific expert
panel;
o Provide technical and secretarial support to the meetings;
o Draft and finalise technical reports concluding on agreements reached
by the scientific expert panel on donor testing and deferral strategies
(including deferral periods) and testing methods for the group of
pathogens covered by the terms of reference;
o Draft and finalise technical guidelines on the prevention of donor-
derived transmission of communicable diseases through SoHO for the
group of pathogens covered by the terms of reference.
2/5
European Centre for Disease Prevention and Control (ECDC)
Gustav den III:s Boulevard 40, 169 73 Solna, Sweden www.ecdc.europa.eu
Phone: +46 (0)8 58 60 10 00 - Fax: +46 (0)8 58 60 10 01
The responsibilities of scientific expert panel members are to:
o Attend the meetings, according to availability, or provide their
contribution by other means;
o Critically review evidence provided by ECDC in the pathogen
fact sheets;
o Provide additional evidence, relevant for the discussion;
o Define needs for additional evidence, if required, to support
panel discussions on specific pathogens;
o Provide expertise on donor selection, screening testing, and
testing methods;
o Provide feedback as requested via surveys sent out by the
ECDC SoHO team;
o Provide ECDC with expert advice on testing strategies and
methods and deferrals (including deferral periods) for the
pathogens under discussion;
o Help to develop and vote on proposals on testing and deferral
strategies. These agreement will serve as a basis for the
drafting of the guidelines;
o Review draft technical reports covering discussions and
agreements reached by the panel, to ensure alignment with
the best practice in the field;
o Support ECDC in the resolution of comments from external
stakeholders on the technical reports;
o Treat in strictest confidence and not make use of or divulge to
third party any information or documents which are linked to
the tasks of the scientific expert panel. To continue to be
bound by this undertaking after completion of the tasks unless
it becomes public;
o Provide and keep up to date, at least on a yearly basis,
declarations of interest throughout the guideline development
process, including informing in a timely fashion ECDC of any
potential conflict of interest that might affect their decisions
and/or actions.
Format and frequency of the
The scientific expert panel meetings will take place online, starting Q2 2023
scientific expert panel
for an estimated period of approximately 12 months, corresponding to six
meetings
meetings.
General structure:
Bimonthly virtual meetings from spring 2023 until agreements (and related
votes) have been recorded for donor assessment topics related to each
pathogen covered by the present terms of reference, and a first closed
consultation on the technical reports has been concluded.
Agreements on testing and deferral strategies as well as testing methods will
be recorded during meetings based on a voting process described during the
first meeting of the panel. Technical reports describing agreements and
agreement levels will serve as reference documents for the drafting of the
guidelines, giving increasing weight with increasing levels of agreement.
1. Meetings to discuss and provide expert advice on testing and deferral
strategies for HIV, HBV, HCV, T. pallidum, and WNV.
Topics will cover:
- Testing strategies
- Deferrals strategies, including deferral periods;
3/5
European Centre for Disease Prevention and Control (ECDC)
Gustav den III:s Boulevard 40, 169 73 Solna, Sweden www.ecdc.europa.eu
Phone: +46 (0)8 58 60 10 00 - Fax: +46 (0)8 58 60 10 01
2. Meetings to discuss and provide expert advice on testing methods for
HIV, HCV, HBV, T. pallidum, and WNV
Topics will cover:
- Testing methods to perform laboratory screening for the
considered pathogens
- Testing methods to perform confirmatory tests for the
considered pathogens;
3. Supporting the drafting of the technical reports: meetings called as
needed.
The duration of the meetings will be based on an agreed meeting agenda.
Meetings will be recorded for the purpose of drafting meeting minutes.
Ad-hoc technical consultation and coordination meetings can be organised
when/if needed to address smaller, focused topics, to assure continuity of
the work and prevent unnecessary delays.
The scientific expert panel will be composed of a maximum of 20 experts
Composition of the scientific
from EU/EEA countries with experience with different types of SoHO
expert panel
considered under the proposed Blood, Tissues & Cells Regulation.
Members of the scientific expert panels shall meet following requirements:
o possess university, or corresponding, degree in the field of medical
or biological sciences;
o have at least 5 years of experience of working in blood, tissue, cells
or medically assisted reproduction establishments, including donor
testing laboratories, on donor selection, donor testing, quality
assurance or as responsible person (in accordance with the art 9 of
the Directive 2002/98/EC and the art 17 of the Directive
2004/23/EC);
or, alternatively, at least 5 years of experience on infectious diseases
covered by these terms of reference, and additional good
understanding of the field of SoHO;
o have experience in evidence-based decision-making;
o have no conflict of interest with the topic, as assessed by ECDC on
the basis of the annual declaration of interest completed via the
ECDC E-DoI platform.
Prior experience in and contributions to the development of technical
standards/guides/guidelines documents, including as part of relevant EU
projects, are desirable.
In the case of departures or noncompliance with responsibilities listed in
these Terms of reference, experts can be replaced, or vacant positions
refilled. Requirements for the selection of these experts shall remain the
same as for the original post.
The recruited experts will not represent countries but be appointed in their
own capacity and areas of expertise. The scientific expert panel will act
exclusively as an independent technical advisory body.
Calls for interest are sent to relevant ECDC expert networks (SoHO-Net and
Selection procedure
other disease and laboratory networks), relevant professional associations,
as well as to the national competent authorities for blood, tissues/cells and
medically assisted reproduction. In addition, the ECDC Expert directory will
be consulted for potential candidates.
4/5
European Centre for Disease Prevention and Control (ECDC)
Gustav den III:s Boulevard 40, 169 73 Solna, Sweden www.ecdc.europa.eu
Phone: +46 (0)8 58 60 10 00 - Fax: +46 (0)8 58 60 10 01
The scientific expert panel members will be selected and proposed for
appointment by ECDC, considering the requirements listed above, and
ensuring reasonable geographical and gender representativeness. Within the
selection procedure individual declarations of conflict of interest will be
thoroughly reviewed and assessed. In addition, ECDC will aim to ensure
sufficient representativeness of each SoHO type (i.e., blood components,
different tissues and cells) in the scientific expert panel.
Once a proposed list of scientific expert panel members has been drawn up,
the ECDC Advisory Forum will be consulted, prior to formal appointment by
the ECDC Director.
Selection of additional or replacement/refill experts shall follow the same
procedure.
Work procedures In principle, meetings of the scientific expert panel will be virtual, and audio-
recorded for the purpose of drafting meeting minutes. Acceptance of the
terms of reference during the first meeting will involve agreement to the
audio-recording of subsequent scientific expert panel meetings. All meetings
will have minutes or action points drafted by ECDC.
Several meetings of the expert panel are expected before covering
agreements on testing and deferral strategies (including deferral periods)
and testing methods for thge whole group of pathogens. The total number
of meetings required in the context of this project and details of their content
may be subject to change and the Terms of reference will be updated
accordingly. Similarly, the creation of working groups focused on specific
topics (e.g., testing methods) may be considered.
Quality aspects of each meeting will be evaluated and based on the results
of these evaluations the necessary organizational changes (e.g., more
frequent shorter meetings, subgroup meetings, etc.) will be implemented.
Terms and conditions of The members of the scientific expert panel will not be remunerated for the
panel members work performed. The outputs of work performed on behalf of ECDC remain
the intellectual property of ECDC and ECDC holds the copyright. ECDC will
acknowledge all members for their work as having been a part of the
guidance scientific expert panel. The final document will be in the public
domain.
5/5
European Centre for Disease Prevention and Control (ECDC)
Gustav den III:s Boulevard 40, 169 73 Solna, Sweden www.ecdc.europa.eu
Phone: +46 (0)8 58 60 10 00 - Fax: +46 (0)8 58 60 10 01