Nomination

Department of Biological Standardisation, OMCL Network & HealthCare (DBO) Substances of Human Origin (SoHO), Quality Section To CD-P-TO Members/Observers, Competent Authorities, DG SANTE RZ/PH/2023-02397L LMA/MPE/he Strasbourg, 19 June 2023 CALL FOR NOMINATION OF EXPERTS Strengthening biovigilance programmes for organs, tissues and cells project Dear colleagues, As part of the Contribution Agreement SANTE/2022/SI2.879517 between the European Commission and the Council of Europe/European Directorate for the Quality of Medicines and HealthCare (EDQM), the EDQM is launching a new project, aimed at strengthening biovigilance programmes for organs, tissues and cells. The objective of this project is to contribute to the improvement of the quality and safety profile of organs, tissues and cells in Europe through: • the identification of good biovigilance practices among Council of Europe member States, and; • the elaboration and dissemination of best practice guidance on how to build up and maintain efficient biovigilance programmes. Further background information on this project is provided in the attached annex. This project will be co-ordinated by the EDQM with the support of a group of experts in the field, called the Biovigilance Working Group (WG). The responsibilities and tasks of the group are defined in the attached terms of reference. The Biovigilance WG will be constituted for a term of 15 months (September 2023 – December 2024). This letter is addressed to the CD-P-TO member States and Observers, EU Competent Authorities in the fields of organs, tissues and cells, and DG SANTE. As informed during the latest CD-P-TO meeting, which took place on 3 – 4 May 2023, the EDQM is calling for the nomination of 20 members to join the Biovigilance WG. Candidates are to be proposed by CD- P-TO members, by national Competent Authorities through DG SANTE or by DG SANTE. The profile of the candidate shall comply with all criteria listed in the section “Composition” of the Terms of reference. .../... Address: 7 Allée Kastner, CS 30026 F – 67081 Strasbourg Tel: +33 (0) 3 88 41 30 30 - Fax: + 33 (0) 3 88 41 27 71 E-mail: Please use the HELPDESK via our internet site: www.edqm.eu  2 Therefore, we invite you to propose candidates, experts in the biovigilance field and willing to contribute to the project. Candidatures should be sent by email to [email protected] by 28 July 2023 at the latest. In submitting the candidatures, please complete the attached Nomination Form, accompanied by the curriculum vitae of the candidate, in which their expertise and experience in the field of biovigilance should be highlighted. Should any proposed candidates wish to receive further information, they may contact the EDQM Secretariat by sending an email to [email protected]. The candidatures will be reviewed by the EDQM Secretariat. Please note that the travel and subsistence expenses of the WG members will be borne by the specific budget appropriations of the EDQM and according to the applicable EDQM rules. With kind regards, Yours sincerely, Laurent Mallet Marie-Pierre Emery Head of DBO Head of Section SoHO Quality Encs: Terms of reference of the Biovigilance working group Nomination form Page 2 of 2 Department of Biological Standardisation, OMCL Network & HealthCare (DBO) Substances of Human Origin (SoHO) Standards Section To CD-P-TO Members and Observers, Competent Authorities, DG SANTE PZ/PH/2023-02421L LMA/MB/mb Strasbourg, 19 June 2023 CALL FOR NOMINATION OF EXPERTS Strengthening Donation after Circulatory Death (DCD) programmes Dear colleagues, In the framework of a new co-operation Contribution Agreement between the European Commission and the EDQM/Council of Europe, the EDQM will be co-ordinating a project aimed at rebuilding organ transplantation programmes by strengthening Donation after Circulatory Death (DCD) programmes in Europe. The project is aimed at identifying best practices for the establishment and development of DCD programmes and, subsequently, elaborating a guide that will help authorities of member States and health professionals to set up new DCD programmes or improve existing DCD programmes. Further background information on this project is provided in the attached annex. This project will be co-ordinated by the EDQM with the support of a group of experts in the field, called the DCD Working Group (WG). The responsibilities and tasks of the group are defined in the attached terms of reference. The DCD WG will be constituted for a term of 15 months (September 2023 – December 2024). This letter is addressed to the CD-P-TO member States and Observers, EU Competent Authorities in the fields of organs, tissues and cells and DG SANTE. As informed during the latest CD-P-TO meeting, which took place on 3 – 4 May 2023, the EDQM is calling for the nomination of 20 members to join the DCD WG. Candidates are to be proposed by CD-P-TO Members, by national Competent Authorities through DG SANTE or by DG SANTE. The profile of the candidate shall comply with all criteria listed in the section “Composition” of the Terms of Reference. Therefore, we invite you to propose candidates, experts in the DCD field and willing to contribute to the project. Candidatures should be sent by email to soho.standards @edqm.eu by 28 July 2023 at the latest. .../... Address: 7 Allée Kastner, CS 30026 F – 67081 Strasbourg Tel: +33 (0) 3 88 41 30 30 - Fax: + 33 (0) 3 88 41 27 71 E-mail: Please use the HELPDESK via our internet site: www.edqm.eu In submitting the candidatures, please complete the attached nomination form, accompanied by the curriculum vitae of the candidate, in which their expertise and experience in the field of DCD should be highlighted. Should any proposed candidates wish to receive further information, they may contact the EDQM Secretariat by sending an email to [email protected]. The candidatures will be reviewed by the EDQM Secretariat. Please note that the travel and subsistence expenses of the working group members will be borne by the specific budget appropriations of the EDQM and according to the applicable EDQM rules. Yours sincerely, Laurent Mallet Mirela Bušić Head of DBO Head of Section SoHO Standards Encs: Terms of Reference of the DCD Working Group Nomination form Page 2 of 2 Department of Biological Standardisation, OMCL Network &amp; HealthCare (DBO) Sub stances of human origin (SoHO) Standard S ection STRE N G T HENING DONATION AFTER CIRCULATORY DEATH PROGRAMMES (DCD WORKING GROUP) NOMINATION FORM NOMINATION FORM TO BE SENT BY 28 July 2023 to E- mail : [email protected] Details of the nominating organisation representative Full name: Organisation: Position: Email: Phone: NOMINATES: Details of the nominated expert Full name : Organisation: A ddress : Country: Email: Phone: Please attach a CV for each candidate , highlighting in particular their expertise and experience in the DCD programme Terms of reference for the Biovigilance Working Group Strengthening biovigilance programmes for organs, tissues and cells project 1. Background The use of any substances of human origin (SoHO) for human application carries some risks for both donors and recipients. These risks can be managed and minimised by the implementation of robust and comprehensive safety and quality systems. However, failures and unexpected events cannot be entirely avoided. Therefore, biovigilance programmes need to be in place to ensure detection and appropriate management of untoward events and reactions as early as possible, and to ensure that appropriate corrective and preventive actions are taken. The setup of biovigilance programmes is an obligation of European Union (EU) member states based on the requirements of EU directive 2005/61/EC. Nevertheless, there is still an important heterogeneity among member states in how those requirements are implemented in practice. 2. Purpose The European Directorate of Quality of Medicines & HealthCare (EDQM) / Council of Europe technical guidelines, namely the Guide to the quality and safety of organs for transplantation and the Guide to the quality and safety of tissues and cells for human application, provide guiding standards in biovigilance. In order to complement this, and to facilitate exchange of experience and share of best practices in biovigilance within the Council of Europe member states, the EDQM is committed to support them in strengthening their biovigilance programmes for organs, tissues and cells project. The expected outcome is the improvement of the quality and safety profile of organs, tissues and cells through the identification and implementation of best biovigilance practices, and strengthened biovigilance programmes in Council of Europe / EU member states. In particular, the project will aim at: - Evaluating the state-of-play of biovigilance programmes currently in place in Europe; - Identify best biovigilance practices, in particular in terms of serious adverse reactions and events (SAREs) management (e.g. detection, investigation/ root cause analysis, alerts and resolution, corrective and preventive actions); - Providing practical guidance for the implementation of effective and efficient biovigilance programmes. The elaborated best practice guidance will be made available free of charge in electronic format on the EDQM website. 1 of 5  3. Period of validity The mandate is valid for the duration of the project up until the publication of the elaborated best practice guidance (estimate December 2024). 4. Tasks and responsibilities – Biovigilance Working Group The Biovigilance Working Group shall undertake the following actions: - Contribute to developing and conducting a survey aiming at mapping biovigilance programmes implemented by authorities and at national level; - Contribute to developing and conducting a survey targeting professionals in the field, aiming at mapping biovigilance programmes implemented at regional and entity level; - Contribute to the analysis of the results of both surveys; - Conduct a literature review and research within relevant databases regarding biovigilance in the fields of organs, tissues and cells; - Identify most common biovigilance practices, critical points to manage, and carry out an assessment of the current practices (conducting a SWOT analysis or using a similar tool); - Prepare a report including survey’s results, recommendations, and strategies that can be expended, action plan and guidance; - Identify needs for establishing guidance or toolkit on biovigilance; - Propose and elaborate guidance and recommendations intended for professionals in the fields on how to implement biovigilance activities in practice, such as SARE management (detection, investigation, root cause analysis, follow-up actions and notification), communication, etc.; - Ensure that the activity is in alignment with the EU legislation, Council of Europe’s technical standards and other initiatives, in particular the work carried out by the Vigilance Expert Subgroup (VES), the European Centre for Disease Prevention and Control (ECDC) and the World Health Organisation (WHO). In doing so, the following results are expected: - Provide professionals involved in biovigilance activities with practical guidance and recommendations on how to implement these activities; - Raise awareness on the risks associated with the use of substances of human origin, the responsibility to report any SAREs, and the importance of biovigilance programmes for ensuring quality and safety for donors and patients; - Strengthen local, regional and national biovigilance programmes in the fields of organs, tissues and cells; - Contribute to ensuring safe and adequate supply of high quality organs, tissues and cells in Europe; - Propose recommendations that can be taken into consideration in the upcoming updates of relevant EU legislation and Council of Europe’s technical standards. 2 of 5  5. Working methods The project will be co-ordinated by the Department of Biological Standardisation, OMCL network & HealthCare (DBO) / EDQM at the Council of Europe. The Biovigilance Working Group will make use of face-to-face meetings, email videoconferences as deemed necessary to ensure the proper rollout of the activities. The Secretariat will produce and distribute reports of the meetings and telephone / video conferences, summarising the decisions and the distribution of tasks. The decisions of the Biovigilance Working Group are taken by consensus. The Biovigilance Working Group will have a Chairperson, elected by simple majority from among the members of the Working Group. If necessary, a Vice-Chairperson may be elected. At least half of the full composition of the Working Group must be present during the election of the Chairperson(s). The election shall be held by a show of hands, unless a member of the Working Group requests a secret ballot. Each member of the Working Group shall have one vote. The Chairperson, with the support of the Secretariat, will be responsible for co-ordinating the work of the Working Group, summing up the conclusions whenever necessary and ensuring deadlines are met. The Secretariat takes charge of the coordination, implementation, dissemination, monitoring, evaluation and improvement of this activity as well as the reporting on the progress of the activity. Other departments from the EDQM may assist the responsible scientific officer in several phases of the project. The project is coordinated in compliance with EDQM internal procedures and relevant standards. 6. Composition of the Biovigilance Working Group The Biovigilance Working Group is composed of a maximum of 20 members. Members should be representatives of national health regulatory / competent authorities, Tissue Establishments (TEs), Organ Procurement Organisation (OPO) and other relevant bodies / professional associations, having responsibilities in implementing biovigilance programmes in the fields of organs, tissues and cells. The members of the Working Group shall: - Have proven experience and expertise in the biovigilance field for organs and / or tissues and cells, in particular in: o SARE management, including detection, investigation, root cause analysis, follow-up actions and notification; o Elaboration of biovigilance-related policies, protocols, guidelines, etc. 3 of 5  o Management of organovigilance and / or tissue and cell vigilance at national / regional / entity level; o OPO and / or TE Quality System Management (QMS); o Inspection of TE (biovigilance programmes). - Have good knowledge of: o The EU legislation applicable to organs, tissues and cells; o The Council of Europe / EDQM Guide to the quality and safety of organs for transplantation; o The Council Europe / EDQM Guide to the quality and safety of tissues and cells for human application. - Be fluent in English. Candidates are proposed by CD-P-TO members, by national competent authorities through DG SANTE or by DG SANTE. Applications are directly addressed to the EDQM Secretariat using the dedicated form accompanied by a Curriculum Vitae (CV). The candidatures are reviewed by the EDQM Secretariat. Selection is based on the technical and scientific expertise of the proposed candidates and should aim at ensuring a broad and balanced geographic and bodies representation. Members of the Working Group shall attend face-to-face meetings (estimate: one per year) and videoconferences, and actively participate in the project activities (see section 4). Permanence as a member in the Working Group can only be guaranteed upon this active engagement in the process. When a member is unable to attend a meeting, a substitute working in close collaboration with the appointed expert may attend the meeting. In this case, the appointed expert shall inform the EDQM Secretariat. The substitute should have a similar knowledge and expertise to the appointed member and his/her CV should be sent to the Secretariat in advance. The Secretariat may invite additional experts to attend one or several meetings if any specific needs arise. Ad hoc experts can be appointed during the term to meet a particular purpose or need. Representatives taking part in the Biovigilance Working Group shall complete a declaration of interests and confidentiality undertaking form. In addition, any potential interest shall be declared before each meeting and recorded in the meeting minutes. Should members of the Biovigilance Working Group change their affiliation (e.g. new position/duties or new place of work) or wish to be replaced during their terms, the members should inform the EDQM Secretariat and their CD-P-TO representative in due course. Changes are subject to approval by their representative and the EDQM Secretariat. 4 of 5  7. Process flow and timelines for the project The project kick-off meeting will be organised as a face-to-face meeting in Strasbourg in September 2023 (estimate: 26 and 27 September). The data collection phase, including the surveys and the literature review, will be conducted from September to December 2023 (estimate). The data analysis and benchmarking phase will be conducted in the first semester of 2024 (estimate). The best practice guidance elaboration will take place between April and October 2024 (estimate). The publication and dissemination of the results is expected to take place before the end of 2024 (estimate: December). 8. Rules and budget The EDQM is responsible for the co-ordination of the project and will cover the costs within the corresponding budgetary limitations and according to the rules detailed in this section. The EDQM will cover the accommodation and travel costs of the Working Group members invited to attend individual Working Group meetings according to the Council of Europe rules and procedures that apply at the time of the meetings. Invitation to attend face-to-face meetings will be based on needs. The EDQM reserves the right to discontinue the financial support to this Working Group at any time during its mandate. 5 of 5 Terms of reference for the DCD Working Group Strengthening Donation after Circulatory Death (DCD) project 1. Background Shortage of organs is the most important barrier to the expansion of transplant therapies across the world. This has been further exacerbated following the COVID-19 pandemic. The majority of transplants are performed with organs derived from donors declared dead using neurological criteria, i.e. donation after brain death (DBD) donors. However, the progressive decline in the pool of potential donors declared dead by neurological criteria (e.g. due to less road accidents leading to fatal head injuries and better treatment options for stroke or a brain aneurysms) and the increasing need for organs for transplantation (e.g. due to the ageing population, increased incidence of diabetes and obesity, etc.) make it increasingly difficult to satisfy the transplantation needs of patients. Countries are thus compelled to look into additional sources of organs for transplantation, which include the consideration of expanded criteria donors and non-standard risk donors, as well as in donation from persons whose death has been determined using circulatory and respiratory criteria, i.e. donation after circulatory death (DCD). Controlled DCD (cDCD) refers to donation from persons whose death has occurred following the decision to withdraw life-sustaining therapies (WLST) which are no longer considered in the best interests of the patients. Uncontrolled DCD (uDCD) refers to donation from persons who die as a result of an unexpected and sudden cardiac arrest for which resuscitation has been unsuccessful. DCD has expanded in such a way that it represented 20% of the 34,854 deceased organ donors reported to the Global Observatory on Organ Donation and Transplantation in 2016. The development of DCD has, however, been variable across countries. DCD is only practiced in a minority of jurisdictions. Activity levels vary, with some countries primarily focusing on uDCD, while cDCD is predominant in others. The regulatory frameworks and the procedures applied are heterogeneous, as are the reported outcomes with the transplantation of DCD donor organs. The European Committee on Organ Transplantation (CD-P-TO) published an updated description of the situation of DCD in member states of the Council of Europe, with a focus on regulatory and organisational features, donation and transplantation activities, effectiveness of the process, and results obtained with DCD donor transplants. 2. Purpose DCD should be considered as an option in all countries, not only to increase the availability of organs to cover the transplant needs of our population, but also to give more patients the opportunity of donating their organs after their death. 1 of 5 Therefore, this project of the European Directorate for the Quality of Medicines and HealthCare (EDQM) aims to support countries to strengthen their donation programmes and increase the availability of organs for transplantation, by compiling best practices and providing tools and recommendations for the development of DCD programmes, in line with the EDQM technical standards provided in the Guide to the quality and safety of organs for transplantation. The expected outcomes are increased number of patients with a given opportunity of donating their organs after their death (increasing thus availability of organs), and rebuilt transplant programs across Europe. In particular, the project will aim at: - Evaluating the state-of-play of DCD programmes/policies currently in place in Europe; - Compelling best DCD practices, in particular in terms of regulatory framework and organisational aspects, donation and transplantation protocols, effectiveness of the process, and results obtained with DCD donor transplants - Providing practical guidance and tools for the implementation of ethically sound and sustainable DCD programme. The elaborated best practice guidance will be made available free of charge in electronic format on the EDQM website. 3. Period of validity The mandate is valid for the duration of the project up until the publication of the elaborated best practice guidance (estimate December 2024). 4. Tasks and responsibilities – DCD Working Group The DCD Working Group shall undertake the following actions: - Contribute to developing and conducting a survey aiming at mapping already implemented DCD programmes/polices and protocols; - Contribute to the analysis of the results of survey - Conduct a literature review and research within relevant databases regarding DCD programs/ policies/practises, - Identify well established DCD practices, critical points to manage, and conducting an analysis/assessment of the current programs/practices (according to agreed criteria); - Prepare a report including survey’s results, recommendations, and strategies that can be expended, action plan and guidance; - Identify needs for establishing guidance, training and toolkit on DCD program; - Propose and elaborate guidance and recommendations intended for professionals and competent/heath authorities on how to implement DCD program in practice. - Ensure that the activity is in alignment with the EU legislation, Council of Europe’s technical standards, the World Health Organisation (WHO) guiding principles and other initiatives, 2 of 5 In doing so, the following results are expected: - Provide health authorities and professionals involved deceased organ donation activities with practical guidance on how to implement DCD program (complement DBD program); - Raise awareness on the both deceased organ donation pathways, in particular DCD; - Strengthen deceased organ donation/transplantation programmes across the Europe; - Contribute to improving supply of high quality organs in Europe; - Propose recommendations that can be taken into consideration in the upcoming updates of relevant EU legislation and Council of Europe’s technical standards. 5. Working methods The project will be co-ordinated by the Department of Biological Standardisation, OMCL network & HealthCare (DBO) / EDQM at the Council of Europe. The Working Group will make use of face-to-face meetings, email and as many videoconferences as deemed necessary to ensure the proper rollout of the activities. The Secretariat will produce and distribute reports of the meetings and telephone / video conferences, summarising the decisions and the distribution of tasks. The decisions of the DCD Working Group are taken by consensus. The Working Group will have a Chairperson, elected by simple majority from among the members of the Working Group. If necessary, a Vice-Chairperson may be elected. At least half of the full composition of the Working Group must be present during the election of the Chairperson(s). The election shall be held by a show of hands, unless a member of the Working Group requests a secret ballot. Each member of the Working Group shall have one vote. The Chairperson, will the support of the Secretariat, will be responsible for co-ordinating the work of the Working Group, summing up the conclusions whenever necessary and ensuring deadlines are met. The Secretariat takes charge of the coordination, implementation, dissemination, monitoring, evaluation and improvement of this activity as well as the reporting on the progress of the activity. Other departments from the EDQM may assist the responsible scientific officer in several phases of the project. The project is coordinated in compliance with EDQM internal procedures and relevant standards. 3 of 5  6. Composition of the DCD Working Group The DCD Working Group is composed of a maximum of 20 members. Members should be representatives of national health regulatory/competent authorities, donor hospitals/Organ Procurement Organisation (OPO), DCD procurement and/or transplantation team, and other relevant bodies / professional associations, having responsibilities in implementing deceased organ donation (DCD) programmes The members of the DCD Working Group shall: - Have proven experience and expertise in the DCD (and/or DBD), in particular in: o Critical Care Management (Prognostication) of Devastating Brain Injury o EoL Intensive/Critical Care (Life Support Treatment) o Deceased Organ Donor Management (DBD/DCD) o DCD procurement and/or transplantation techniques - Have good knowledge of o Legal and ethical aspect relevant for the deceased organ donation o The EU legislation applicable to organs o The Council of Europe/EDQM Guide to the quality and safety of organs for transplantation o WHO guiding principles in organ donation/transplantation o WHO Critical pathway on Deceased Organ Donation - Be fluent in English. Candidates are proposed by CD-P-TO members, by national Competent Authorities through DG SANTE or by DG SANTE. Applications are directly addressed to the EDQM Secretariat using the dedicated form accompanied by a Curriculum Vitae. The candidatures are reviewed by the EDQM Secretariat. Selection is based on the technical and scientific expertise of the proposed candidates and should aim at ensuring a broad and balanced geographic and bodies representation. Members of the Working Group shall attend face-to-face meetings (estimate: one per year) and videoconferences, and actively participate in the project activities (see section 4). Permanence as a member in the Working Group can only be guaranteed upon this active engagement in the process. When a member is unable to attend a meeting, a substitute working in close collaboration with the appointed expert may attend the meeting. In this case, the appointed expert shall inform the EDQM Secretariat. The substitute should have a similar knowledge and expertise to the appointed member and his/her CV should be sent to the Secretariat in advance. The Secretariat may invite additional experts to attend one or several meetings if any specific needs arise. Ad hoc experts can be appointed during the term to meet a particular purpose or need. 4 of 5 Representatives taking part in the DCD WG shall complete a declaration of interests and confidentiality undertaking form. In addition, any potential interest shall be declared before each meeting and recorded in the meeting minutes. Should members of the DCD Working Group change their affiliation (e.g. new position/duties or new place of work) or wish to be replaced during their terms, the members should inform the EDQM Secretariat and their CD-P-TO representative in due course. Changes are subject to approval by their representative and the EDQM Secretariat. Representatives taking part in theDCD Working Group shall complete a declaration of interests and confidentiality undertaking form. In addition, any potential interest shall be declared before each meeting and recorded in the meeting minutes. 7. Process flow and timelines for the project The project kick-off meeting will be organised as a face-to-face meeting in Strasbourg in September 2023 (estimate: 18 and 19 September). The data collection phase, including the surveys and the literature review, will be conducted from September to December 2023 (estimate). The data analysis and benchmarking phase will be conducted in the first semester of 2024 (estimate). The best practice guidance elaboration will take place between April and October 2024 (estimate). The publication and dissemination of the results is expected to take place before the end of 2024 (estimate: December). 8. Rules and budget The EDQM is responsible for the co-ordination of the project and will cover the costs within the corresponding budgetary limitations and according to the rules detailed in this section. The EDQM will cover the accommodation and travel costs of the Working Group members invited to attend individual Working Group meetings according to the Council of Europe rules and procedures that apply at the time of the meetings. Invitation to attend face-to-face meetings will be based on needs. The EDQM reserves the right to discontinue the financial support to this group at any time during its mandate. 5 of 5 Saatja: <[email protected]> Saadetud: 03.07.2023 18:16 Adressaat: <[email protected]> Koopia: <[email protected]> Teema: Calls for nomination - Biovigilance and DCD projects Manused: image001.png; image002.png; Call for nomination_Biovigilance WG.pdf; Nomination form_Biovigilance WG.docx; Terms of reference_Biovigilance WG.pdf; Call for nomination_DCD WG.pdf; Nomination form_DCD WG.docx; Terms of reference_DCD WG.pdf Dear colleagues in the national SoHO authorities, Please find below a call for vigilance experts from the European Directorate for the Quality of Medicines and Healthcare. With kind regards, SANTE SoHO team ********************************** CALL FOR NOMINATION OF EXPERTS Strengthening biovigilance programmes project As part of the Contribution Agreement SANTE/2022/SI2.879517 between the European Commission and the Council of Europe/European Directorate for the Quality of Medicines and HealthCare (EDQM), the EDQM is launching a new project, aimed at strengthening biovigilance programmes for substances of human origin (SoHO), in particular for organs, tissues and cells. The objective of this project is contribute to the improvement of the quality and safety profile of these SoHO in Europe through: - The identification of good biovigilance practices for professionals among Council of Europe member states, and; - The elaboration and dissemination of best practice guidance on how to efficiently participate in biovigilance programmes. The initiative will focus on organs, tissues and cells vigilance, however leveraging on existing expertise in haemovigilance. This project will be coordinated by the EDQM with the support of a group of experts in the field, called the Biovigilance Working Group (WG). It will be closely aligned to the work from the Vigilance Expert Subgroup (VES) and other ongoing initiatives. Please find attached our letter, reference 2023-02397L, regarding the Call for nominations of experts to be part of the Biovigilance WG. Also attached are the Terms of Reference of the working group and the nomination form. Please complete a separate nomination form for each expert you wish to nominate. All forms and CVs should be returned to the SoHO Quality Section of the EDQM Secretariat at [email protected]. Deadline: 28 July 2023 If you require any further information, please don't hesitate to contact the Secretariat at [email protected] With kind regards, The EDQM team Department of Biological Standardisation, OMCL Network &amp; HealthCare (DBO) Substances of human origin (SoHO) Quality S ection STRENGTHENING BIOVIGILANCE PROGRAMMES FOR ORGANS, TISSUES AND CELLS (BIOVIGILANCE WORKING GROUP) NOMINATION FORM NOMINATION FORM TO BE SENT BY 28 July 2023 to E- mail : [email protected] Details of the nominating organisation representative Full name: Organisation: Position: Email: Phone: NOMINATES: Details of the nominated expert Full name : Organisation: A ddress : Country: Email: Phone: Please attach a CV for each candidate , highlighting in particular their expertise and experience in the biovigilance field for organs and / or tissues and cells