Saatja: <
[email protected]>
Saadetud: 22.03.2023 11:13
Adressaat: <
[email protected]>; EDQM Transplantation
<
[email protected]>
Koopia: <
[email protected]>
Teema: EDQM CALL FOR NOMINATIONS - 6th ed Guide to the quality and safety of tissues
and cells for human application: EDQM-2023-01013-mail
Manused: image001.png; image002.png; image003.jpg
Dear Competent Authorities for Tissues and Cells,
Please find below a message from EDQM regarding the call for experts in 6th ed Guide to the quality and
safety of tissues and cells for human application.
Please centralise all nominations coming from the same country rather than having each CA from each
country nominating own experts. Thus, centralising nominations via CD-P-TO representatives would be
ideal in order not to surpass the limit of 2 candidates per country. This would be particularly important
in this edition where there is a very limited number of vacant sports available (6).
Should you have any question, please contact EDQM directly at the email address provided.
Best regards,
The SoHO team.
European Commission
DG SANTE (Health and Food Safety)
Unit B4 – Medical Products: quality, safety, innovation
Office address: Rue Breydel 2, 06/004, B-1049 Brussels/Belgium
http://ec.europa.eu/health/blood_tissues_organs/policy/index_en.htm
EUROPEAN COMMITTEE ON ORGAN
TRANSPLANTATION (CD-P-TO)
10/03/2023
Dear CD-P-TO representatives,
The 5th edition of the Guide to the quality and safety of tissues and cells
for human application was published in December 2022. The launch of the
process of preparing the next 6th edition is planned to take place the first
quarter of 2023 with a duration until 2025.
Due to the complexities that the elaboration of the next edition will entail in
the context of the digitalisation of the guide, which will require a full
restructuring of the text, profound knowledge of the content of the latest TC
Guide will be required. Therefore, we have decided to provide continuity to
the working group that elaborated the previous edition to maximise
effectiveness and efficiency in the process. In this manner, the next edition
will be a transitional edition where changes will focus on structure and
presentation of the text rather than on in-depth revision of the technical
guidance per se.
Accordingly, we approached the Working Group of the 5 edition to confirm
th
who would be available to work on the 6 edition. The conclusion is that
th
85% of the working group members will be available to participate in the
elaboration of this transitional edition. Therefore, a nomination process will
be open to fill in 6 spots vacant in the working group. Due to the existing
expertise in the current working group, we would appreciate to receive
nominations for experts with in-depth and practical knowledge in the
following fields:
Medically assisted reproduction and/or fertility preservation
Quality management in the context of tissue establishments, ideally
with expertise in audits/inspections
Microbiology testing in the context of tissue establishments
We encourage all member states and observers to the CD-P-TO, National
Transplant Organisations and/or Ministries of Health from Council of
Europe member states and observers, as well as relevant international
professional associations to nominate their candidates so that realities and
experience of all European countries could be taken into account. The
nomination form for an appointment of experts is attached to this email.
Deadline for nomination of experts is 30 March 2023. Please send your
nomination forms to the Secretariat at
[email protected].
We remain at your disposal for any additional questions or information.
With kind regards,
Janet Latzel, on behalf of:
Marta LÓPEZ FRAGA, Ph.D.
Scientific Officer
European Committee on Organ Transplantation (CD-P-TO)
Department of Biological Standardisation, OMCL Network & HealthCare (DBO)
European Directorate for the Quality of Medicines & HealthCare (EDQM), Council of
Europe
7 Allée Kastner, Cs 30026
F-67081 Strasbourg (FRANCE)
Tel: +33 (0)3 90 21 45 30
Fax: +33 (0)3 88 41 27 71
To learn more about the work of the EDQM in the areas of organ, tissue and cell
donation and
transplantation, please visit our webpage: http://www.edqm.eu/en/organ-
transplantation-mission-67.html
https://www.edqm.eu and https://www.edqm.eu/store You can also contact us via
HelpDesk
Confidentiality Notice:
This e-mail and any attached files may contain confidential information that is intended only for the addressee(s).
If you are not the intended recipient, you are hereby notified that any disclosure, copying, distribution, or reliance
upon the contents of this e-mail (including any attached files) is strictly prohibited. Anyone who receives this
message
in error should notify the sender immediately by using the reply function and then permanently delete this e-mail
(including any attached files). Thank you.
************************************************************
****************
Please make sure to include in any reply our mail reference: EDQM-2023-
01013-mail
Saatja:
[email protected] <
[email protected]>
Saaja:
[email protected], EDQM Transplantation,
[email protected]
Teema: EDQM CALL FOR NOMINATIONS - 6th ed Guide to the quality and safety of tissues and cells for human application: EDQM-2023-01013-mail
Dear Competent Authorities for Tissues and Cells,
Please find below a message from EDQM regarding the call for experts in 6th ed Guide to the quality and safety of tissues and cells for human application.
Please centralise all nominations coming from the same country rather than having each CA from each country nominating own experts. Thus, centralising nominations via CD-P-TO representatives would be ideal in order not to surpass the limit of 2 candidates per country. This would be particularly important in this edition where there is a very limited number of vacant sports available (6).
Should you have any question, please contact EDQM directly at the email address provided.
Best regards,
The SoHO team.
European Commission
DG SANTE (Health and Food Safety)
Unit B4 – Medical Products: quality, safety, innovation
Office address: Rue Breydel 2, 06/004, B-1049 Brussels/Belgium
http://ec.europa.eu/health/blood_tissues_organs/policy/index_en.htm
EUROPEAN COMMITTEE ON ORGAN TRANSPLANTATION (CD-P-TO)
10/03/2023
Dear CD-P-TO representatives,
The 5th edition of the Guide to the quality and safety of tissues and cells for human application was published in December 2022. The launch of the process of preparing the next 6th edition is planned to take place the first quarter of 2023 with a duration until 2025.
Due to the complexities that the elaboration of the next edition will entail in the context of the digitalisation of the guide, which will require a full restructuring of the text, profound knowledge of the content of the latest TC Guide will be required. Therefore, we have decided to provide continuity to the working group that elaborated the previous edition to maximise effectiveness and efficiency in the process. In this manner, the next edition will be a transitional edition where changes will focus on structure and presentation of the text rather than on in-depth revision of the technical guidance per se.
Accordingly, we approached the Working Group of the 5th edition to confirm who would be available to work on the 6th edition. The conclusion is that 85% of the working group members will be available to participate in the elaboration of this transitional edition. Therefore, a nomination process will be open to fill in 6 spots vacant in the working group. Due to the existing expertise in the current working group, we would appreciate to receive nominations for experts with in-depth and practical knowledge in the following fields:
* Medically assisted reproduction and/or fertility preservation
* Quality management in the context of tissue establishments, ideally with expertise in audits/inspections
* Microbiology testing in the context of tissue establishments
We encourage all member states and observers to the CD-P-TO, National Transplant Organisations and/or Ministries of Health from Council of Europe member states and observers, as well as relevant international professional associations to nominate their candidates so that realities and experience of all European countries could be taken into account. The nomination form for an appointment of experts is attached to this email.
Deadline for nomination of experts is 30 March 2023. Please send your nomination forms to the Secretariat at
[email protected].
We remain at your disposal for any additional questions or information.
With kind regards,
Janet Latzel, on behalf of:
Marta LÓPEZ FRAGA, Ph.D.
Scientific Officer
European Committee on Organ Transplantation (CD-P-TO)
Department of Biological Standardisation, OMCL Network & HealthCare (DBO)
European Directorate for the Quality of Medicines & HealthCare (EDQM), Council of Europe
7 Allée Kastner, Cs 30026
F-67081 Strasbourg (FRANCE)
Tel: +33 (0)3 90 21 45 30
Fax: +33 (0)3 88 41 27 71
To learn more about the work of the EDQM in the areas of organ, tissue and cell donation and
transplantation, please visit our webpage: http://www.edqm.eu/en/organ-transplantation-mission-67.html <https://urldefense.com/v3/__http:/www.edqm.eu/en/organ-transplantation-mission-67.html__;!!DOxrgLBm!DL94NO80vJa0V3cVF4IW5mDLCAX6Kf-OGAXeLXYobXAgzSN2GSnvAGXYv4c_BJTskQnOCj-zAr8JiXE4PmrInRf4Fo_CLvSvZVjBEhPYT7ci$>
https://www.edqm.eu <https://urldefense.com/v3/__https:/www.edqm.eu/__;!!DOxrgLBm!DL94NO80vJa0V3cVF4IW5mDLCAX6Kf-OGAXeLXYobXAgzSN2GSnvAGXYv4c_BJTskQnOCj-zAr8JiXE4PmrInRf4Fo_CLvSvZVjBEnF5bn19$> and https://www.edqm.eu/store <https://urldefense.com/v3/__https:/www.edqm.eu/store__;!!DOxrgLBm!DL94NO80vJa0V3cVF4IW5mDLCAX6Kf-OGAXeLXYobXAgzSN2GSnvAGXYv4c_BJTskQnOCj-zAr8JiXE4PmrInRf4Fo_CLvSvZVjBEpLfDnH3$> You can also contact us via HelpDesk <https://urldefense.com/v3/__https:/helpdesk.edqm.eu/servicedesk/customer/user/login?destination=portals__;!!DOxrgLBm!DL94NO80vJa0V3cVF4IW5mDLCAX6Kf-OGAXeLXYobXAgzSN2GSnvAGXYv4c_BJTskQnOCj-zAr8JiXE4PmrInRf4Fo_CLvSvZVjBEgjbiH-U$>
Confidentiality Notice:
This e-mail and any attached files may contain confidential information that is intended only for the addressee(s).
If you are not the intended recipient, you are hereby notified that any disclosure, copying, distribution, or reliance
upon the contents of this e-mail (including any attached files) is strictly prohibited. Anyone who receives this message
in error should notify the sender immediately by using the reply function and then permanently delete this e-mail
(including any attached files). Thank you.
****************************************************************************
Please make sure to include in any reply our mail reference: EDQM-2023-01013-mail